Carestream Pacs

• • Ongoing Z-0497-2025 FDA Class II ·initiated 10 Oct 2024

  A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorrect ischemic map and table values.

• 49 recalls, same reason

  • Terminated Z-0246-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0215-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0260-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0230-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0238-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0243-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0236-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0256-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0235-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0254-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0240-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0226-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0249-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0211-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0231-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0255-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0232-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0221-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0212-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0259-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0217-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0223-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0228-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0225-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0224-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0227-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0214-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0241-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0242-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0258-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0257-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0239-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0234-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0248-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0220-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0213-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0245-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0253-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0251-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0233-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0216-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0237-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0252-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0222-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0218-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0229-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0250-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0244-2014 FDA Class II ·initiated 16 Sep 2013
  • Terminated Z-0219-2014 FDA Class II ·initiated 16 Sep 2013

  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.

1. 16 Sep 2013 Recall initiated FDA recalls Z-0216-2014
2. 16 Sep 2013 Recall initiated FDA recalls Z-0237-2014
3. 16 Sep 2013 Recall initiated FDA recalls Z-0252-2014
4. 16 Sep 2013 Recall initiated FDA recalls Z-0222-2014
5. 16 Sep 2013 Recall initiated FDA recalls Z-0218-2014
6. 16 Sep 2013 Recall initiated FDA recalls Z-0229-2014
7. 16 Sep 2013 Recall initiated FDA recalls Z-0250-2014
8. 16 Sep 2013 Recall initiated FDA recalls Z-0244-2014
9. 16 Sep 2013 Recall initiated FDA recalls Z-0219-2014
10. 10 Oct 2024 Recall initiated FDA recalls Z-0497-2025

41 earlier events are in the sections above.

510(k) Number

K110919 ↗

FDA product code

LLZ

Device class

Class II

Regulation

21 CFR Part 892.2050

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

• PLUG 'N VIEW 3D, VERSION 1.0 by Voxar Limited
• MODIFICATION TO ENCOMPASS by Heartlab, Inc.
• NIO 3MP-21 by Barcoview
• Ez3D-i/E3 by Ewoosoft Co., Ltd.
• JUPITER PROCESSING AND REVIEW WORKSTATION by GE MEDICAL SYSTEMS, INC.
• LIFERX by Bowdengs Technologies, LLC
• PHILIPS ORTHOPAEDIC APPLICATIONS by Philips Medical Systems North America, Inc.
• UROCARE by Neusoft Medical Systems Co., Ltd.
• Aycan Workstation Osirix Pro by AYCAN DIGITALSYSTEME GMBH
• 21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258) by JVCKENWOOD Corporation

• Lux HD 43

  Class IIa

  CE/MDR

• Lux HD 2530

  Class IIa

  CE/MDR

• Lux HD 35 Detector

  Class IIa

  CE/MDR

• Q-RAD System

  Class II

  FDA 510(k) K011486 Active Cleared 20 Jun 2001 GUDID on market

See all devices from Carestream Health, Inc. →