GE — Class II medical device recall Z-0023-2014
Terminated recall by GE Healthcare, LLC, reported 2013-10-23, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen
| Recall number | Z-0023-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-03-26 |
| Classified | 2013-10-17 |
| Reported by FDA | 2013-10-23 |
| Terminated | 2013-12-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BH, CA, CH, CL, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GT, GY, ID, IN, IQ, IT, JO, JP, KR, KW, LV, NL, NO, NZ, PK, PL, RO, RU, SA, SE, TH, TR, TW, UA, VN, ZA |
| Serial numbers | 00000026193YC3, 00000026850YC8, 00000027396YC1, 00000027886YC1, 00000030752YC0, 00000031032YC6, 00000031572YC1, 00000033194YC2, 00000033407YC8, 00000034263YC4, 00000034384YC8, 00000034385YC5, 00000034790YC6, 00000037282YC1, 00000037592YC3, 00000037593YC1, 00000037723YC4, 00000037908YC1, 00000037909YC9, 00000038151YC7, 00000038153YC3, 00000038154YC1, 00000038737YC3, 00000038738YC1, 00000038739YC9 and 354 more |
Product
GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID
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-0023-2014. 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.