GE Healthcare — Class II medical device recall Z-1616-2013
Terminated recall by GE Healthcare, LLC, reported 2013-07-10, distributed in AZ, CA, CO, FL, ID, IL, ME, NC…. GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator
| Recall number | Z-1616-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2011-05-16 |
| Classified | 2013-06-28 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2014-03-13 |
| Distributed | AZ, CA, CO, FL, ID, IL, ME, NC, NV, NY, OK, TN, UT, WI |
| Countries outside the US | CA, CL, DE, ES, FR, IT, JP, KR, NO |
| Quantity | 48 |
| Serial numbers | 00000007C20103, 00000007C20141, 00000007C20150, 00000007C20173, 00000009C20099, 0000000DUMMY01, 0000009C2M0040, 0000009C2M0041, 0000009C2M0077, 0000009C2M0084, 0000009C2M0108, 0000009C2M0167, 0000010C2M0005, 0000010C2M0027, 0000010C2M0063, 0000010C2M0069, 0000010C2M0083, 0000010C2M0088, 0000010C2M0097, 0000010C2M0121, 0000010C2M0122, 0000010C2M0130, 0000010C2M0137, 0000010C2M0143, 0000010C2M0159 and 23 more |
Product
GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures.
Reason for recall
GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems.
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-1616-2013. 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.