Three 40KWFXPLUS X-ray systems recalled with reminder about improper cleaning
Sedecal is recalling three model 40KWFXPLUS.004 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 40KWFXPLUS.004, 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 three units, serial numbers G84489, G84504 and G84589, distributed in California, Illinois and New Jersey. The enforcement record lists the UDI/DI as unknown. 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 40KWFXPLUS.004, 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 (4)
- UDI/DI unknown
- Serial Numbers: G84489
- G84504
- G84589.
Distribution
Distributed in 3 states:
- CA
- IL
- NJ
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