Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0271-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
- Manufacturer
- SEDECAL SA
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 08436046001510
- Serial Numbers: D11-40KW-F
- G36689
- G37293
- G38198
- G38657
- G38385
- G37687
- G36643
- G41114
- G36137
- G36761
- G36272
- G37188
- G37359
- G37456
- G38178
- G62012
- G62059
- G62892
Distribution
Distributed in 3 states:
- CA
- IL
- NJ
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