FDA Device recall Z-0261-2026
Model Number SM-40HF-Batt
- 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-Batt 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-0261-2026 |
| 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-Batt; 40KW ANALOG, 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 08436046001114, Serial Numbers: G24948, G25512, C25673, 25901, G25771, G26990, G25506, G22189, G30240. |
|---|
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-0261-2026%22
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