FDA-Device2021-09-08Class II
CombiDiagnost R90 Software Version R1.0 and R1.1
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.
Sold states
US Nationwide Distribution
Affected count
322 systems; 66 in US
Manufactured in
Development And Manufacturing Ctr., Rontgenstr. 24-26, Hamburg, N/A, Germany
Products
CombiDiagnost R90 Software Version R1.0 and R1.1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2357-2021Don't want to check this manually?
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