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CARESTREAM HEALTH, INC.

Last updated September 17, 2026

Information

Country: US
Address: 882 Linden Ave., Rochester, NY, 14625
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3015532525
DUNS Number: 793169512

Catalogue (1455)

Page 5 of 30

Device	Model / Reference	Registries	Class	Status
Qw-420-T	QW-420-T	FDA UDI	Class I	Active
DRX - Ascend System	DRX - Ascend System	FDA UDI	Class II	Unknown
CS 7600 Hygienic Sheath	CS 7600 Hygienic Sheath	FDA UDI	Class I	Active
DRX - Ascend System	DRX - Ascend System	FDA UDI	Class II	Active
Full Blue X-ray Film WB	Full Blue X-ray Film WB	FDA UDI	Class I	Active
DRX-Compass X-ray System	DRX-Compass X-ray System	FDA UDI	Class II	Active
MIN-R 2 Cassette with MIN-R 2000 Screen	MIN-R 2 Cassette with MIN-R 2000 Screen	FDA UDI	Class II	Unknown
4343R Digital Image Receptor	4343R Digital Image Receptor	FDA UDI	Class II	Active
Full Blue X-ray Film WB	Full Blue X-ray Film WB	FDA UDI	Class I	Unknown
DRX - Ascend System	DRX - Ascend System	FDA UDI	Class II	Active
T-Mat G/Ra	T-MAT G/RA	FDA UDI	Class I	Active
TRIMAX 4343FC Detector	DETECTOR,PACKED,TRIMAX,4343FC	FDA UDI	Class II	Active
True Speed Bucky	True Speed Bucky	FDA UDI	Class I	Active
Q-RAD System	Q-RAD System	FDA UDI	Class II	Active
Q-RAD System	Q-RAD System	FDA UDI	Class II	Active
Qw-420	QW-420	FDA UDI	Class I	Active
Q-RAD System	Q-RAD System	FDA UDI	Class II	Active
Vita Flex CR Long Length Imaging System	Vita Flex CR Long Length Imaging System	FDA UDI	Class II	Active
Medical X-ray Cassette with Green 400 Screens	Medical X-ray Cassette with Green 400 Screens	FDA UDI	Class II	Active
DRYVIEW DVB Laser Imaging Film	DRYVIEW DVB Laser Imaging Film	FDA UDI	Class I	Unknown
Medical X-ray Green / MXG Film	Medical X-ray Green / MXG Film	FDA UDI	Class I	Unknown
Q-RAD System	Q-RAD System	FDA UDI	Class II	Active
Q-Rad System	Q-Rad System	FDA UDI	Class II	Unknown
CS 7600 Hygienic Sheath	CS 7600 Hygienic Sheath	FDA UDI	Class I	Active
Medical X-ray Blue / MXB Film	Medical X-ray Blue / MXB Film	FDA UDI	Class I	Active
DRYVIEW DVB Laser Imaging Film	DRYVIEW DVB Laser Imaging Film	FDA UDI	Class I	Active
TEE Transesophageal Transducer	TEE Transesophageal Transducer	FDA UDI	Class II	Unknown
DIRECTVIEW CR Cassette with PQ Screen	DIRECTVIEW CR Cassette with PQ Screen	FDA UDI	Class II	Active
DRYVIEW DVB Laser Imaging Film	DRYVIEW DVB Laser Imaging Film	FDA UDI	Class I	Active
Select Cassette with LANEX Fast Screens	Select Cassette with LANEX Fast Screens	FDA UDI	Class I	Unknown
Q-RAD System	Q-RAD System	FDA UDI	Class II	Active
MIN-R 2000 Plus Film	MIN-R 2000 Plus Film	FDA UDI	Class I	Active
DRYVIEW DVE Laser Imaging Film	DRYVIEW DVE Laser Imaging Film	FDA UDI	Class I	Active
DRX-Revolution Mobile X-ray System	DRX-Revolution Mobile X-ray System	FDA UDI	Class II	Unknown
Vita Cr Long Length Imaging System	VITA CR LONG LENGTH IMAGING SYSTEM	FDA UDI	Class II	Active
Qg-40-3	QG-40-3	FDA UDI	Class I	Active
DRX-Compass X-ray System	DRX-Compass X-ray System	FDA UDI	Class II	Active
Vita CR System	Vita CR System	FDA UDI	Class II	Active
DRX Plus 4343 DETECTOR	DRX Plus 4343 DETECTOR	FDA UDI	Class II	Active
DRX - Ascend System	DRX - Ascend System	FDA UDI	Class II	Active
Classic CR System	Classic CR System	FDA UDI	Class II	Active
MIN-R 2 Cassette with MIN-R EV 190 Screen	MIN-R 2 Cassette with MIN-R EV 190 Screen	FDA UDI	Class I	Active
Flexible Phosphor Screen GP-2	Flexible Phosphor Screen GP-2	FDA UDI	Class I	Active
Q-RAD System	Q-RAD System	FDA UDI	Class II	Active
DIRECTVIEW CR Cassette with PQ Screen	DIRECTVIEW CR Cassette with PQ Screen	FDA UDI	Class II	Active
Q-RAD System	Q-RAD System	FDA UDI	Class II	Active
DRX Plus 3543C Detector	DRX Plus 3543C Detector	FDA UDI	Class II	Active
DRYVIEW DVB Laser Imaging Film	DRYVIEW DVB Laser Imaging Film	FDA UDI	Class I	Active
Q-RAD System	Q-RAD System	FDA UDI	Class II	Active
TRIMAX 4343 Detector	DETECTOR,PACKED,TRIMAX,4343	FDA UDI	Class II	Active

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FDA Recalls (92)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 2, 2023	Z-0289-2024	—	open, classified	There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable.
Oct 2, 2023	Z-0437-2024	—	open, classified	Unexpected failure of electrical components within the CPI generator.
Jan 30, 2023	Z-1206-2023	—	open, classified	After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result in a injury
Jan 6, 2020	Z-0806-2020	—	terminated	Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.
Mar 19, 2019	Z-1207-2019	—	terminated	When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.
May 25, 2017	Z-2651-2017	—	terminated	Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.
Jan 12, 2017	Z-1138-2017	—	terminated	The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.
Nov 21, 2016	Z-1052-2017	—	terminated	Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting measurement unit is not displayed, i.e., centimeters or millimeters. As such, the user expects that the measurement is taken calculated in centimeters, consistent with other values in the report. In actuality, the measurement is taken in millimeters. When this updated measurement is used in an average calculation, the result appears incorrect as two measurements are interpreted as centimeters while the user corrected value is interpreted as millimeters. If the user selects a Calc Result display as Min or Max, the values are also interpreted as millimeters when centimeters were expected.
Jul 8, 2016	Z-2217-2016	—	terminated	A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of the anatomy may appear enlarged or distended when it actually is not.
Apr 15, 2016	Z-1594-2016	—	terminated	Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".
Apr 15, 2016	Z-1593-2016	—	terminated	Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".
Aug 7, 2015	Z-2449-2015	—	terminated	Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.
Jan 8, 2015	Z-1377-2015	—	terminated	Units device head descended unexpectedly
Jan 8, 2015	Z-1378-2015	—	terminated	Units device head descended unexpectedly
Nov 25, 2014	Z-0800-2015	—	terminated	While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution Mobile X-Ray System in which bolts that secure the x-ray tube assembly/boom to the device mounting block may break. It has been determined that this issue is a result of an improperly assembled part which holds the x-ray
Oct 30, 2014	Z-0820-2015	—	terminated	Reduced mammographic image quality when attempting to print true size multi-format images
Jul 9, 2014	Z-2177-2014	—	terminated	An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engineering. Inspection of these parts revealed that the tab on the lock washer was not bent into the lock nut recess and because the Beta Assembly detached from the OTC telescope, the lock nut was not sufficiently tightened.
Jul 2, 2014	Z-2143-2014	—	terminated	The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.
Jul 2, 2014	Z-2142-2014	—	terminated	The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees.
May 30, 2014	Z-2137-2014	—	terminated	A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object.
Jan 24, 2014	Z-1127-2014	—	terminated	Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
Jan 24, 2014	Z-1128-2014	—	terminated	Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
Dec 26, 2013	Z-0844-2014	—	terminated	Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.
Nov 25, 2013	Z-0797-2014	—	terminated	Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.
Nov 25, 2013	Z-0796-2014	—	terminated	Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.
Nov 25, 2013	Z-0798-2014	—	terminated	Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.
Sep 16, 2013	Z-0228-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0248-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0221-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0259-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0218-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0230-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0219-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0233-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0239-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0224-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0256-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0255-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0216-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0242-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0222-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0241-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0226-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0257-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0214-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0225-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0251-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0211-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0227-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0212-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0250-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0213-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0244-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0253-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0217-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0235-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0237-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0246-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0254-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0232-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0260-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0215-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0245-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0249-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0240-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0231-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0243-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0234-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0252-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0247-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0229-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0238-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0258-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0236-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0220-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Sep 16, 2013	Z-0223-2014	—	terminated	Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Aug 29, 2013	Z-0180-2014	—	terminated	Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure
Aug 29, 2013	Z-0491-2014	—	terminated	It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system.
Aug 29, 2013	Z-0179-2014	—	terminated	Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure
Aug 20, 2013	Z-0774-2014	—	terminated	Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system allowed an exposure without the assignment of a bucky or image receptor.
Jul 26, 2013	Z-0090-2014	—	terminated	During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the detector is not calibrated before use.
Jun 19, 2013	Z-0132-2014	—	terminated	Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.
Jun 6, 2013	Z-0126-2014	—	terminated	Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch.
Jun 3, 2013	Z-1877-2013	—	terminated	Due to potential for an x-ray exposure technique change.
Jan 17, 2013	Z-0744-2013	—	terminated	Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only a
Jun 12, 2012	Z-2202-2012	—	terminated	Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.
Dec 20, 2011	Z-0746-2012	—	terminated	Kodak DryView DVB Film is being recalled because it does not meet the specification for maximum density.
Mar 12, 2010	Z-1314-2010	—	terminated	Product mix-up. The firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it was performing like T-MAT G/RA.
Mar 12, 2010	Z-1315-2010	—	terminated	Product mix-up. The firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it was performing like T-MAT G/RA.
Dec 21, 2007	Z-0731-2008	—	terminated	Unintended Positioner Movement - The U-Arm Positioner starts to move 1) without command from the operator and/or 2) can unexpectedly start movement if the system is powered down and re-energized after a collision has occurred with the Quantum Table.
Mar 6, 2007	Z-0717-2007	—	terminated	The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR).
Mar 6, 2007	Z-0738-2007	—	terminated	The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR).