Twelve mobile X-ray units recalled with reminder about water resistance limits
Sedecal is recalling 12 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant and must be cleaned strictly per the manual.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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-710CW, 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 12 units carrying UDI/DI 08436046002166, with serial numbers including G83204, G82622, G79677, G79194, G82129, G79632, G79837 and G79924, 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 40KWFXPLUS-710CW, Mobile X-ray system
- Manufacturer
- SEDECAL SA
- Category
- Medical Device — Mobile X-ray
- Affected units
- 12
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 (13)
- UDI/DI 08436046002166
- Serial Numbers: G83204
- G82622
- G79677
- G79194
- G82129
- G79632
- G79837
- G79924
- G84490
- G84640
- G79699
- G84605.
Distribution
Part of a larger recall action
This product is one of 46 recalled by SEDECAL SA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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