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Philips Medical Systems Gmbh, DMC Recall 88393

Description: CombiDiagnost R90 Software Version R1.0 and R1.1

Philips Medical Systems Gmbh, DMC Recall 88393 Information

Mandated?FDA Mandated
Recall NumberZ-2357-2021
Event ID88393
Event DescriptionCombiDiagnost R90 Software Version R1.0 and R1.1
Product TypeDevices
DistributionUS Nationwide Distribution
Quantity322 systems; 66 in US
Recall ReasonPhilips 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.
Device Classification20210908
Device Code InfoModel 706100
Center Classification Date20210828
Recall Initiation Date20200722
Recalling FirmPhilips Medical Systems Gmbh, DMC
Initial Notification Letter
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