Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a… — Class II medical device recall Z-0118-2014
Terminated recall by Ge Healthcare It, reported 2013-11-06, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patient
| Recall number | Z-0118-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ge Healthcare It, Barrington, IL, United States |
| Recall initiated | 2012-06-15 |
| Classified | 2013-10-30 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2016-06-10 |
| Distributed | 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, VI, WA, WI, WV, WY |
| Countries outside the US | AE, AT, BE, BH, BR, CA, CH, DE, EG, ES, FR, GB, GH, HU, IE, IL, IT, JP, KW, LB, LT, MX, NG, NL, PL, QA, RU, SA, SI, TR, ZA |
| Quantity | 847 units |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0118-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.