GE Healthcare Precision 500D — Class II medical device recall Z-0911-2014
Terminated recall by GE Healthcare, LLC, reported 2014-02-12, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MP
| Recall number | Z-0911-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-12-12 |
| Classified | 2014-02-03 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-09-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BG, CA, CH, CL, DE, DO, ES, GB, HN, IE, IT, KW, LB, MT, PT, RO, RU, SA, SK, TR, TW, VE |
| Model numbers | 205387WRF6, 205783PRF4, 205939SVRF1, 207369RF1, 207454RF1, 208227ROOM6, 208678500D, 208786PREC, 210572RF1, 210575MSTH2, 210916BRF1, 214352PREC1, 215537ERMCRF1, 215538PRE1, 217442VXF3A, 217876DRF1, 217935WF1, 218634P500, 218741P500, 225763RF1, 225924RF1, 225924RF2, 228377RF10, 228377RF9, 228467P500 and 305 more |
Product
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor). There is a potential for the locking nut to loosen out of the LCD Video Monitor Suspension yoke. This will not lead to an immediate fall of the suspended monitor since it will
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-0911-2014. 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.