Company: Philips Medical Systems Gmbh, DMC
Date of Enforcement Report: 9/8/2021
Class II
PRODUCT
CombiDiagnost R90 Software Version R1.0 and R1.1
Recall Number: Z-2357-2021
REASON
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.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Gmbh, DMC on 7/22/2020. FDA Mandated.
VOLUME OF PRODUCT IN COMMERCE
322 systems; 66 in US
DISTRIBUTION
U.S. Nationwide