[pending] Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0266-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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/60C, 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 (2)
- UDI/DI 08436046001510
- Serial Numbers: G33585
Distribution
Distributed in 3 states:
- CA
- IL
- NJ
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