PENTAX of America, Inc.
Also registered as Pentax Medical of America, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 1000080301
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 336 ongoing
What PENTAX of America, Inc. makes
PENTAX of America, Inc. manufactures medical devices including radiology information systems, electroglottographs, flexible video colonoscopes, flexible video gastroscopes, endoscopic video image display units, rigid optical nasopharyngoscopes, endoscopic video image processing units, and flexible video bronchoscopes.
The company's portfolio includes Class I and Class II devices listed in the FDA 510(k) and FDA UDI registries. PENTAX of America, Inc. is based in the US.
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
PENTAX Video Upper G.I. Scope EG34-i10 Ref K180292
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1000080301
- Address
- 3 Paragon Drive, MONTVALE, NJ, 07645
FDA recalls
FDA recall records list 33 recalls initiated by PENTAX of America, Inc., the earliest on 2011-01-11 and the most recent on 2025-07-16. By recorded status: 6 ongoing and 27 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 8
- 2018 6
- 2019 0
- 2020 4
- 2021 3
- 2022 0
- 2023 0
- 2024 0
- 2025 4
- 2026 0
2025
- 16 Jul 2025 Z-2329-2025 Class II Ongoing During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.
- 29 Jan 2025 Z-1236-2025 Class II Ongoing During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
- 29 Jan 2025 Z-1237-2025 Class II Ongoing During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
- 29 Jan 2025 Z-1238-2025 Class II Ongoing During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
2021
- 14 Jul 2021 Z-2448-2021 Class II Ongoing Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
- 14 Jul 2021 Z-2449-2021 Class II Ongoing Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
- 21 Apr 2021 Z-1682-2021 Class II Terminated IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure and updated to notify users of what immediate actions should be taken in case the event occurs. This can result in unforseen events such as mucosal injury, lacerations, or bleeding of the patient. Detachment of the distal end cap (OE-A63) into the oral cavity of the patient may also result in aspiration
Full distribution text
2020
- 22 Sep 2020 Z-0292-2021 Class II Terminated There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.
- 22 Sep 2020 Z-0293-2021 Class II Terminated There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.
- 3 Jan 2020 Z-1267-2020 Class II Terminated Distributed in the USA without an approved 510K
Show the 25 most recent of 33 recalls
2020
- 3 Jan 2020 Z-1268-2020 Class II Terminated Distributed in the USA without an approved 510K
2018
- 3 Dec 2018 Z-0970-2019 Class II Terminated The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
Full distribution text
- 3 Dec 2018 Z-1325-2019 Class II Terminated Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
Full distribution text
- 3 Dec 2018 Z-1326-2019 Class II Terminated Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
Full distribution text
- 3 Dec 2018 Z-1327-2019 Class II Terminated Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
Full distribution text
- 30 Mar 2018 Z-2256-2018 Class II Terminated The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. In this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller.
- 13 Feb 2018 Z-0643-2018 Class II Terminated The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy.
Full distribution text
- 3 Dec 2018 Z-0970-2019 Class II Terminated The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
2017
- 13 Jul 2017 Z-0615-2018 Class II Terminated The video cytoscopes lack 510(k) premarket notification clearance.
- 23 May 2017 Z-3067-2017 Class II Terminated Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.
- 23 May 2017 Z-3068-2017 Class II Terminated Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.
- 13 Apr 2017 Z-2742-2017 Class II Terminated Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
- 13 Apr 2017 Z-2743-2017 Class II Terminated Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
- 13 Apr 2017 Z-2744-2017 Class II Terminated Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
- 13 Apr 2017 Z-2745-2017 Class II Terminated Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
- 17 Jan 2017 Z-2713-2017 Class II Terminated Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.
Full distribution text
Frequently asked questions
How many devices does PENTAX of America, Inc. have in the registry?
The registry currently lists 2 devices for PENTAX of America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list PENTAX of America, Inc.'s devices?
Among its 2 most recently registered devices, PENTAX of America, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do PENTAX of America, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for PENTAX of America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for PENTAX of America, Inc.?
FDA recall records list 33 recalls initiated by PENTAX of America, Inc., the most recent initiated on 16 Jul 2025. 6 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from PENTAX of America, Inc. in the registry?
The most recently registered devices listed for PENTAX of America, Inc. include PENTAX Video Upper G.I. Scope EG34-i10 and PENTAX Medical Video Colonoscope EC34-i10T Series.