Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CombiDiagnost R90 Software Version R1.0 and R1.1 Recalled by Philips Medical Systems Gmbh, DMC Due to Philips has become aware of a software issue,...

Date: July 22, 2020
Company: Philips Medical Systems Gmbh, DMC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems Gmbh, DMC directly.

Affected Products

CombiDiagnost R90 Software Version R1.0 and R1.1

Quantity: 322 systems; 66 in US

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips Medical Systems Gmbh, DMC

Philips Medical Systems Gmbh, DMC has 33 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report