FDA Device recall Z-0612-2019
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
- FDA Device
- Class II
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class II recall of Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System by Philips Medical Systems Dmc, citing kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0612-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-07 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips Medical Systems Dmc |
| Distribution | US |
Product
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Reason
kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.
Identifiers
| code_info | All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0612-2019%22
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