GE Revolution CT The system is intended for head — Class II medical device recall Z-1915-2016
Terminated recall by GE Healthcare, LLC, reported 2016-06-15, distributed nationwide. GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in uninte
| Recall number | Z-1915-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2016-05-09 |
| Classified | 2016-06-06 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2018-09-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BR, CA, CH, CN, DE, DK, EE, ES, FR, GB, HK, ID, IT, JP, KR, KW, MX, NO, NZ, PE, PL, SA, SE, SG, TW |
Product
GE 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
GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie
Machine access
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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.