CombiDiagnost R90 Software Version R1.0 and R1.1 recall: Software Issue
CombiDiagnost R90 Software Version R1.0 and R1.1
Why was CombiDiagnost R90 Software Version R1.0 and R1.1 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model 706100
- Product
- CombiDiagnost R90 Software Version R1.0 and R1.1
- Recalling firm
- Philips Medical Systems Gmbh, DMC
- Quantity
- 322 systems; 66 in US
- Distribution
- US Nationwide Distribution
- Recall date
- September 8, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)