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Philips Medical Systems Gmbh, DMC recalls CombiDiagnost R90 Software Version R1.0 and R1.1
Recalled September 8, 2021 · FDA recall Z-2357-2021 · Philips Medical Systems Gmbh, DMC
Hazard
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. · FDA Class II
Units
322 systems; 66 in US
Sold at
US Nationwide Distribution
Description
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.
Product
CombiDiagnost R90 Software Version R1.0 and R1.1
Manufacturer(s)
Philips Medical Systems Gmbh, DMC
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →