Six 40KW mobile X-ray units recalled with strict cleaning reminder
Sedecal is recalling six SM-40HF-B-D-C 40KW.002 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a precautionary user notification: the record describes a reminder about cleaning instructions rather than a defect, with no reported harm.
Plain-English summary
The Sedecal mobile X-ray system, model SM-40HF-B-D-C (40KW.002), is subject to a recall consisting of a customer notification.
Sedecal sent an email to its consignees reminding 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 recall covers six units carrying UDI/DI 08436046001510, serial numbers G39544, G62558, G71736, G40116, G65568 and G65570, distributed in California, Illinois and New Jersey. The FDA has classified the action as Class II.
The enforcement record describes a user reminder rather than a device defect, and reports no injuries. Sites should follow the cleaning instructions in the manual.
The recalled product
- Product
- Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
- Manufacturer
- SEDECAL SA
- Category
- Medical Device — Mobile X-ray
- Hazard
- user-notification
- cleaning-instructions
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 (7)
- UDI/DI 08436046001510
- Serial Numbers: G39544
- G62558
- G71736
- G40116
- G65568
- G65570.
Distribution
Distributed in 3 states:
- CA
- IL
- NJ
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