FDA Device recall Z-1202-2023
Phoenix mKDR, digital mobile diagnostic x-ray system
- FDA Device
- Class II
- ongoing
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Phoenix mKDR, digital mobile diagnostic x-ray system by Sedecal, citing sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1202-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-06 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sedecal |
| Distribution | n/a |
Product
Phoenix mKDR, digital mobile diagnostic x-ray system
Reason
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Identifiers
| code_info | UDI/DI 08436046003002, Serial Numbers: PH00092, PH00093, PH00094, PH00095, PH00097, PH00098, PH00099, PH00100, PH00110…UDI/DI 08436046003002, Serial Numbers: PH00092, PH00093, PH00094, PH00095, PH00097, PH00098, PH00099, PH00100, PH00110, PH00111, PH00112, PH00113, PH00114, PH00115, PH00116, PH00117, PH00118, PH00135, PH00136, PH00137, PH00138, PH00139, PH00140, PH00141, PH00142, PH00143, PH00144, PH00161, PH00162, PH00163, PH00164, PH00165, PH00166, PH00167, PH00168, PH00169, PH00176, PH00177, PH00178, PH00179, PH00180, PH00181, PH00185, PH00186, PH00187, PH00188, PH00189, PH00190, PH00191, PH00192, PH00010, PH00090, PH00091 |
|---|
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-1202-2023%22
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