System — Class II medical device recall Z-2258-2020
Ongoing recall by GE Healthcare, LLC, reported 2020-06-10, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently u
| Recall number | Z-2258-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2018-11-30 |
| Classified | 2020-06-03 |
| Reported by FDA | 2020-06-10 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WI, WV |
| Countries outside the US | AR, AU, BE, BR, CA, CO, DE, DK, FR, GB, GH, IL, IN, IT, JP, KR, MX, NL, NO, NZ, PL, PT, SE, SG, TH, TR, TW |
| Quantity | 526 units |
| Reason classes | software |
| Serial numbers | 00000000VEN002, 00000000VEN003, 0000E3GT08038A, 0000E3GT09163A, 11001, 11002, 11003, 11004, 11007, 11008, 11009, 11010, 11014, 11017, 11018, 11021, 11022, 11023, 11025, 11026, 11027, 11029, 11030, 11031, 11032 and 328 more |
Product
System, Tomography Computed Emmission
Reason for recall
GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature was being used; the software on the system was not current.
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-2258-2020. 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.