GE Healthcare — Class II medical device recall Z-1989-2014
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-1989-2014 |
|---|---|
| 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 | 1,053 |
| UPC / GTIN / UDI-DI | 00000000000246, 00000000001199, 00000000001250, 00000000001274, 00000000001366, 00000000001380, 00000000001458, 00000000001502, 00000000001564, 00000000001694, 00000000001762, 00000000001830, 00000000001847, 00000000001908, 00000000001915, 00000000002073, 00000000002080, 00000000002158, 00000000002165, 00000000002172, 00000000002189, 00000000002257, 00000000002363, 00000000002387, 00000000002400 and 43 more |
Product
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems 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-1989-2014. 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.