SED URS LP X-ray system recalled with water resistance reminder
Sedecal is recalling the SED URS LP mobile X-ray system, serial 40116, after emailing consignees to remind users that the equipment is not water-resistant.
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 SED URS LP mobile X-ray system 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 affected unit carries serial number 40116 and was distributed in California, Illinois and New Jersey. The enforcement record lists no quantity and gives 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. The site should follow the cleaning instructions in the manual.
The recalled product
- Product
- SED URS LP, Mobile X-ray system
- Manufacturer
- SEDECAL SA
- Category
- Medical Device — Mobile X-ray
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 unknown
- Serial Numbers: 40116
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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