Video Monitor Suspensions that may be on the following Fluoroscopic… — Class II medical device recall Z-0804-2014
Terminated recall by GE Healthcare, LLC, reported 2014-01-29, distributed nationwide. Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the o
| Recall number | Z-0804-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-11-08 |
| Classified | 2014-01-21 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2014-11-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IR, IS, IT, JM, JO, JP, KR, KW, LB, MA, MT, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, PY, RO, RS, RU, SA, SE, SK, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 5,651 |
| Serial numbers | 00000000045GP5, 00000000047GP1, 00000000120GP6, 00000000159728, 00000000167GP7, 00000000168GP5, 00000000169GP3, 00000000170GP1, 00000000171GP9, 00000000175GP0, 00000000177GP6, 00000000180GP0, 00000000182GP6, 00000000184GP2, 00000000185GP9, 00000000186GP7, 00000000190GP9, 00000000223GQ8, 00000000252GP7, 00000000254GP3, 00000000256GP8, 00000000259GP2, 00000000277GQ4, 00000000331GP9, 00000000334GP3 and 475 more |
Product
Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII Product Usage: The systems are intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations on both adult and pediatric subjects. The systmes are used 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
Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the system. GE is not aware of any fall of the overhead monitor suspension.
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-0804-2014. 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.