Reported Sep 8, 2021 · Ongoing
CombiDiagnost R90 Software Version R1.0 and R1.1
Philips Medical Systems GmbH, DMC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems Gmbh, DMC · Development And Manufacturing Ctr. · Hamburg, N/A · N/A
Is this the product you have?
- CombiDiagnost R90 Software Version R1.0 and R1.1
- Lot codes and dates
- Model 706100
- Amount recalled
- 322 systems; 66 in US
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips Medical Systems GmbH, DMC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.