Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1130-2021 — System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.

U.S. FDA — Device Enforcement · United States · 2020-12-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1130-2021
Date of alert
2020-12-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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