GE PET Discovery 610 — Class II medical device recall Z-0024-2014
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-0024-2014 |
|---|---|
| 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 |
Product
GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
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-0024-2014. 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.