Recall – Flouroscopy system software error leads to over or under exposed image

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

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