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

Recall Z-2357-2021 — CombiDiagnost R90 Software Version R1.0 and R1.1

U.S. FDA — Device Enforcement · Germany · 2020-07-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2357-2021
Date of alert
2020-07-22
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems Gmbh, DMC
Product category
device
Product type
Devices
Reported risk: Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.
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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