Recall Z-2357-2021— Philips Medical Systems Gmbh, DMC

Name: FDA recall Z-2357-2021
Creator: U.S. Food and Drug Administration
Published: 2020-07-22

Class II · Ongoing

Class II FDA medical device recall by Philips Medical Systems Gmbh, DMC, initiated 2020-07-22. It names one FDA 510(k) clearance: K203087. Product: CombiDiagnost R90 Software Version R1.0 and R1.1. Reason: 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..

Recalling firm: Philips Medical Systems Gmbh, DMC
Classification: Class II
Status: Ongoing
Initiated: 2020-07-22
Firm location: Hamburg, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K203087 — CombiDiagnost R90Philips Medical Systems Dmc GmbH·cleared 2020-12-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.