FDA Device recall Z-0182-2023
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
- FDA Device
- Class II
- ongoing
- Published 2022-11-16
On 2022-11-16 the FDA classified a Class II recall of Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500 by Sedecal, citing due to un-commanded movement of mobile x-ray unit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0182-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-12 |
| Published | 2022-11-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sedecal |
| Distribution | AL, AR, AZ, CA, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, ME, MI, MN, MO, MS, MT, NC, NV, NY, OH, OK, PA, RI, SD, TN, TX, UT, VA, WA, WI, WV, WY |
Product
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
Reason
Due to un-commanded movement of mobile x-ray unit.
Identifiers
| code_info | Model: Soltus 450 Type / UDI-DI Code: 10451 /08436046002555 10451-1 / 08436046002562 10451-2 / 08436046002531 10451-3…Model: Soltus 450 Type / UDI-DI Code: 10451 /08436046002555 10451-1 / 08436046002562 10451-2 / 08436046002531 10451-3 / 08436046002548 Serial Numbers / UDI Codes: SLS000014 (01)08436046002555(240)10451(11)200700(21)SLS000014 SLS000038 (01)08436046002555(240)10451(11)200800(21)SLS000038 SLS000039 (01)08436046002555(240)10451(11)200800(21)SLS000039 SLS000040 (01)08436046002555(240)10451(11)200900(21)SLS000040 SLS000046 (01)08436046002555(240)10451(11)200900(21)SLS000046 SLS000048 (01)08436046002555(240)10451(11)201000(21)SLS000048 SLS000050 (01)08436046002555(240)10451(11)201000(21)SLS000050 SLS000051 (01)08436046002555(240)10451(11)201000(21)SLS000051 SLS000077 (01)08436046002555(240)10451(11)201100(21)SLS000077 SLS000078 (01)08436046002555(240)10451(11)201000(21)SLS000078 SLS000079 (01)08436046002555(240)10451(11)201100(21)SLS000079 SLS000080 (01)08436046002555(240)10451(11)201100(21)SLS000080 SLS000081 (01)08436046002555(240)10451(11)201100(21)SLS000081 SLS000082 (01)08436046002555(2 |
|---|
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-0182-2023%22
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