Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0265-2026.
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 55C, 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 (6)
- UDI/DI 08436046001510
- Serial Numbers: G35462
- G-32753
- G35480
- G33111
- G33721.
Distribution
Distributed in 3 states:
- CA
- IL
- NJ
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