GE Healthcare — Class II medical device recall Z-1989-2013
Terminated recall by GE Healthcare, LLC, reported 2013-08-28, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspe
| Recall number | Z-1989-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-05-02 |
| Classified | 2013-08-20 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2013-11-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, FR, GB, IT, PA, SA |
| Serial numbers | 00000002608GQ8, 00000002609GQ6, 00000002734GQ2, 00000002735GQ9, 00000002736GQ7, 00000002838GQ1, 00000003208GQ6, 00000003209GQ4, 00000004078GQ2, 00000004079GQ0, 00000004083GQ2, 00000004084GQ0, 00000004086GQ5, 00000004087GQ3, 00000004102GQ0, 00000004103GQ8, 00000004104GQ6, 00000004105GQ3, 00000004106GQ1, 00000004107GQ9, 00000004108GQ7, 00000004109GQ5, 00000004873GQ6, 00000004874GQ4, 00000004875GQ1 and 420 more |
Product
GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and
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-1989-2013. 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.