FDA Device recall Z-0258-2026
Model Number SM-40HF-B-D-C
- FDA Device
- Class II
- ongoing
- Published 2025-10-29
On 2025-10-29 the FDA classified a Class II recall of Model Number SM-40HF-B-D-C by Sedecal, citing sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, cle….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0258-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-10 |
| Published | 2025-10-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Sedecal |
| Distribution | CA, IL, NJ |
Product
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Reason
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Identifiers
| code_info | UDI/DI 08436046001510, Serial Numbers: G25456, G25508, G25681, G25698, G25930, G27630, G27705, C-25709, G22652, G38643,…UDI/DI 08436046001510, Serial Numbers: G25456, G25508, G25681, G25698, G25930, G27630, G27705, C-25709, G22652, G38643, G25673, G27664, G25708, G25689, G25457, C08042, G25641, G25663, G24234, G25517, G23833, G23945, G23954, G25458, G25528, G27497, G27497/584, G27651, G27689, G22586, G24220, G25755, G26016, G25529, G25396, G27792, C25709, G27701, G30684. |
|---|
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-0258-2026%22
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