GE Healthcare — Class II medical device recall Z-1988-2014
Terminated recall by GE Healthcare, LLC, reported 2014-07-09, distributed in DC, GU, PR, VT. GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a ser
| Recall number | Z-1988-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-06-04 |
| Classified | 2014-07-02 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2015-05-06 |
| Distributed | DC, GU, PR, VT |
| Countries outside the US | AE, AR, AT, AU, BG, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, ID, IE, IL, IQ, IS, IT, JM, JO, JP, KR, KW, LB, LT, LV, MA, MT, MX, MY, NG, NI, NL, NO, NZ, PA, PH, PK, PL, PT, RO, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 3,460 |
| UPC / GTIN / UDI-DI | 00082407040100, 00082407040209, 00082407040216, 00082407040360, 00082407040377, 00082407050055, 00082407070077, 00082407120062, 00082407150021, 00082407160082, 00082407160198, 00082407190034, 00082407290024 |
Product
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Reason for recall
GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.
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-1988-2014. 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.