SM_40HF_B_D_VIR3, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0284-2026.
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
- SM_40HF_B_D_VIR3, 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 (18)
- UDI/DI 08436046002166
- Serial Numbers: G86476
- G86632
- G86634
- G85447
- G86619
- G85453
- G85461
- G86477
- G86633
- G87334
- G87335
- G87336
- G87353
- G86617
- G87337
- G85335
- G85452.
Distribution
Distributed in 3 states:
- CA
- IL
- NJ
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