Philips Medical Systems Gmbh, DMC: Medical Device Recall in 2021 - (Recall #: Z-2357-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

CombiDiagnost R90 Software Version R1.0 and R1.1

Product Classification:

Class II

Date Initiated: July 22, 2020

Date Posted: September 8, 2021

Recall Number: Z-2357-2021

Event ID: 88393

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.

Status: Ongoing

Product Quantity: 322 systems; 66 in US

Code Information:

Model 706100

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated