GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic… — Class II medical device recall Z-1966-2015
Terminated recall by GE Healthcare, reported 2015-07-08, distributed nationwide. The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is i
| Recall number | Z-1966-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2015-06-12 |
| Classified | 2015-07-02 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2015-12-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BE, BM, CA, CL, CO, CZ, DE, DO, EC, EG, ES, FR, GB, GH, GT, HN, ID, IE, IL, IT, JM, JO, KR, KW, KY, MT, MX, MY, NZ, PA, RO, RU, SA, TH, TR, TW, VE, VN |
| Model numbers | 00000001189M30, 00000001235M31, 00000001271M39, 00000001431M36, 00000001433M32, 00000001653M35, 00000001838M32, 00000001887M39, 00000002216M30, 00000002347M33, 00000002349M39, 00000002466M31, 00000002640M31, 00000002641M39, 00000002643M35, 00000002772M32, 00000002773M30, 00000002776M33, 00000002778M39, 00000002874M36, 00000002981M39, 00000003053M36, 00000003055M31, 00000003056M39, 00000003193M30 and 475 more |
Product
GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Legacy and Legacy D Table is intended for use in a diagnostic X-ray system to support patient during general purpose radiological procedures in the horizontal, vertical and Trendelenburg positions.
Reason for recall
The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.
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-1966-2015. 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.