medical Class II Updated 2021-09-08

Philips Medical Systems Gmbh, DMC recalls CombiDiagnost R90 Software Version R1.0 and R1.1

Recalled Product

CombiDiagnost R90 Software Version R1.0 and R1.1

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model 706100
View official government recall

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