CombiDiagnost R90 Software Version R1.0 and R1.1
Reported: September 8, 2021 Initiated: July 22, 2020 #Z-2357-2021
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.
Details
- Recalling Firm
- Philips Medical Systems Gmbh, DMC
- Units Affected
- 322 systems; 66 in US
- Distribution
- US Nationwide Distribution
- Location
- Hamburg, N/A
Frequently Asked Questions
What product was recalled? ▼
CombiDiagnost R90 Software Version R1.0 and R1.1. Recalled by Philips Medical Systems Gmbh, DMC. Units affected: 322 systems; 66 in US.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 8, 2021. Severity: Moderate. Recall number: Z-2357-2021.
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