Philips Medical Systems Gmbh, DMC Recall 88393
Description: CombiDiagnost R90 Software Version R1.0 and R1.1
Philips Medical Systems Gmbh, DMC Recall 88393 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-2357-2021 |
| Event ID | 88393 |
| Event Description | CombiDiagnost R90 Software Version R1.0 and R1.1 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 322 systems; 66 in US |
| Recall Reason | 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. |
| Device Classification | 20210908 |
| Device Code Info | Model 706100 |
| Center Classification Date | 20210828 |
| Recall Initiation Date | 20200722 |
| Recalling Firm | Philips Medical Systems Gmbh, DMC |
| Initial Notification | Letter |
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