GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless… — Class II medical device recall Z-1078-2014
Terminated recall by GE Healthcare, LLC, reported 2014-03-05, distributed nationwide. GE Healthcare has recently become aware of a software issue associated with patient selection from the worklis
| Recall number | Z-1078-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-01-20 |
| Classified | 2014-02-24 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2014-11-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, CA, FR, GB, IE, IT, JO, RO, RU |
| Reason classes | software |
Product
GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended for use in all routine radiography exams, and specialized areas including pediatric work, intensive care and trauma, wherever conventional screen-film systems or CR systems may be used. The device is not intended for mammography or fluoroscopy applications.
Reason for recall
GE Healthcare has recently become aware of a software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option) that may impact patient safety. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the WDR1 are not properly displayed. I
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-1078-2014. 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.