GE Healthcare — Class II medical device recall Z-0401-2016
Terminated recall by GE Medical Systems, LLC, reported 2015-12-16, distributed nationwide. GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT sca
| Recall number | Z-0401-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2015-10-23 |
| Classified | 2015-12-10 |
| Reported by FDA | 2015-12-16 |
| Terminated | 2016-05-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BR, CA, CH, CN, DE, DK, ES, FR, GB, HK, ID, IT, JP, KR, KW, NO, PE, PL, SA, SE, TW |
Product
GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.
Reason for recall
GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue.
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-0401-2016. 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.