FDA Device recall Z-0118-2014
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from…
- FDA Device
- Class II
- terminated
- Published 2013-11-06
On 2013-11-06 the FDA classified a Class II recall of Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from… by Ge Healthcare It, citing multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0118-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-15 |
| Published | 2013-11-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare It |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
Product
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.
Reason
Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixe
Identifiers
| code_info | Software Versions: 3.7.1, 3.7.1.1, 3.7.2, 3.7.3.1, 3.7.3.3, 3.7.3.4, 3.7.3.5, 3.7.6.3, 3.7.3.7, and 3.7.3.8 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Ge Healthcare It
- Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data
FDA Device · Class II · 2016-09-14 · Ge Healthcare It - Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the…
FDA Device · Class II · 2016-09-07 · Ge Healthcare It - GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic an…
FDA Device · Class II · 2016-08-24 · Ge Healthcare It - Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be…
FDA Device · Class II · 2016-08-03 · Ge Healthcare It - Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data
FDA Device · Class II · 2014-12-31 · Ge Healthcare It
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0118-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.