Discovery PET/CT 610 Product Usage: The systems are intended for head… — Class II medical device recall Z-1745-2019
Ongoing recall by GE Healthcare, LLC, reported 2019-06-26, distributed nationwide. GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
| Recall number | Z-1745-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-02-12 |
| Classified | 2019-06-19 |
| Reported by FDA | 2019-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,113 in |
Product
Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
Reason for recall
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
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-1745-2019. 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.