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

Recall date

July 22, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2357-2021

FDA classification

Class II

Brand / firm

Philips Medical Systems Gmbh, DMC

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CombiDiagnost R90 Software Version R1.0 and R1.1