FDA Device recall Z-2357-2021
CombiDiagnost R90 Software Version R1.0 and R1.1
- FDA Device
- Class II
- ongoing
- Published 2021-09-08
On 2021-09-08 the FDA classified a Class II recall of CombiDiagnost R90 Software Version R1.0 and R1.1 by Philips Medical Systems Dmc, citing 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 L….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2357-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-07-22 |
| Published | 2021-09-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Medical Systems Dmc |
| Distribution | US |
Product
CombiDiagnost R90 Software Version R1.0 and R1.1
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.
Identifiers
| code_info | Model 706100 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2357-2021%22
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