GE Healthcare — Class II medical device recall Z-1551-2013
Terminated recall by GE Healthcare, LLC, reported 2013-06-26, distributed in CA, CO, CT, FL, GA, IL, NC, NY…. GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST resp
| Recall number | Z-1551-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-05-09 |
| Classified | 2013-06-18 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2014-01-21 |
| Distributed | CA, CO, CT, FL, GA, IL, NC, NY, OH, TX, VA, WI, WV |
| Countries outside the US | AT, AU, CA, CH, CL, CZ, DE, DK, ES, FI, FR, GB, HK, ID, IN, IT, JP, KR, MA, MX, NG, PL, RO, RU, SA, SE, TH, TR, TW, ZA |
| Serial numbers | 00000L021DFE17, 00000L2E5D97AC, 00000L3A3318C4, 00000L3A331FA4, 00000L3AA73A5B, 00000L3AA80D28, 00000L3AB4D639, 00000L3AB4D6CC, 00000L3AB50126, 00000L3AB501ED, 00000L3AB67847, 00000L97BF02A6, 00000LA704C3E7, 00000LA707B8CD, 00000LA70AB28E, 00000LA70D61FE, 00000LA70D6257, 00000LAEDF9764, 00000LE23E908A, 00000LFB44C088, 00000X12335005, 0000G297117701, 0000S704783AWS, 000D1L3AB67847, 000S704783HDCT and 4 more |
Product
GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in the PET VCAR application on Advantage Workstation or AW Server.
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-1551-2013. 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.