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Open, Classified

CombiDiagnost R90 Software Version R1.0 and R1.1

FDA Recall Z-2357-2021 · Posted None

Recalling FirmPhilips Medical Systems Gmbh, DMC
Recall StatusOpen, Classified
Product CodeJAA
Date Initiated2020-07-22
Product Quantity322 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.

Firm Action

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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K203087CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2020-12-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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