FDA recall Z-2357-2021

Philips Medical Systems Gmbh, DMC · Class II · device

Product

CombiDiagnost R90 Software Version R1.0 and R1.1

Reason for recall

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.

Distribution

US Nationwide Distribution

Key facts

Status: Ongoing
Initiation date: 2020-07-22
Report date: 2021-09-08
Voluntary/Mandated: FDA Mandated
Location: Hamburg, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2357-2021