RecallDepth

CombiDiagnost R90 Software Version R1.0 and R1.1

Company
Philips Medical Systems Gmbh, Dmc Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany
Recall Initiated
July 22, 2020
Recall Number
Z-2357-2021
Quantity
322 systems; 66 in US

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

Lot / Code Info

Model 706100

Root Cause

Radiation Control for Health and Safety Act

Action Taken

Philips sent customers an Electronic Product Radiation Correction letter dated July 14, 2021. The letter identified the affected product, problem and actions to be taken. Philips plans to correct the defect at no cost to customers by implementing a field correction involving the installation of a software update. For questions contact the Customer Care Solutions Center 1-800-722-9377 and reference FCO70900051.