System — Class II medical device recall Z-1130-2021
Terminated recall by GE Healthcare, LLC, reported 2021-02-24, distributed nationwide. GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revol
| Recall number | Z-1130-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2020-12-17 |
| Classified | 2021-02-17 |
| Reported by FDA | 2021-02-24 |
| Terminated | 2023-01-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BR, CA, CH, CN, DE, DK, DZ, EE, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IT, JO, JP, KE, KR, KW, LT, MA, MT, MX, MY, NL, NO, NZ, PE, PH, PL, PT, QA, RU, SA, SE, SG, SK, TH, TR, TW, VN |
| Quantity | 1,115 units |
| Model numbers | 00000396676HP9, 000003993CN1, 00000436925CN2, 00000436942CN7, 00000437410CN4, 00000437624CN0, 00000437849CN3, 00000438247CN9, 00000438438CN4, 00000438902CN9, 00000438994CN6, 00000439205CN6, 00000439234CN6, 00000439287CN4, 00000439368CN2, 00000439407CN8, 00000439505CN9, 00000439537CN2, 00000439632CN1, 00000439660CN2, 00000439754CN3, 00000439777CN4, 00000439799CN8, 00000439823CN6, 00000439834CN3 and 475 more |
Product
System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
Reason for recall
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.
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-1130-2021. 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.