Revolution CT systems with the SmartStep Option The system is… — Class II medical device recall Z-0776-2019
Ongoing recall by GE Healthcare, LLC, reported 2019-02-13, distributed nationwide. On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation
| Recall number | Z-0776-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2018-07-12 |
| Classified | 2019-02-06 |
| Reported by FDA | 2019-02-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CH, DE, EE, FI, FR, GB, HK, IE, JP, KR, MA, MY, NO, NZ, SA, SE, SG, SK, TH, TR |
| Quantity | 131 units |
Product
Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Reason for recall
On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator
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-0776-2019. 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.