FDA Device recall Z-1754-2024
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt
- FDA Device
- Class II
- ongoing
- Published 2024-05-08
On 2024-05-08 the FDA classified a Class II recall of Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt by Sedecal, citing potential interference with the anti-fall system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1754-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-22 |
| Published | 2024-05-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Sedecal |
| Distribution | US |
Product
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (AeroDR X30); i. SM-50HF-B-D-KM (AeroDR X30); j. MobileDiagnost wDR.
Reason
Potential interference with the anti-fall system.
Identifiers
| code_info | All serial numbers of model 3.1 Battery Mobile X-ray Unit EASY MOVING are affected. Following are the UDI numbers invo…All serial numbers of model 3.1 Battery Mobile X-ray Unit EASY MOVING are affected. Following are the UDI numbers involved: a. SM-20HF-Batt - UDI-DI 08436046001497 b. SM-32HF-Batt - UDI-DI 08436046001503 c. SM-40HF-Batt - UDI-DI 08436046001510; d. SM-50HF-Batt - UDI-DI 08436046001527; e. SM-40-HF-B-D-VIR - UDI-DI 08436046002166; f. SM-20HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002579; g. SM-32-HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002586; h. SM-40HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002593; i. SM-50HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002609; j. MobileDiagnost wDR - UDI-DI 08436046002357. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1754-2024%22
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