Battery analog 40KW X-ray systems recalled with water resistance reminder
Sedecal is recalling nine SM-40HF-Batt 40KW analog 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-Batt (40KW ANALOG), 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 nine units carrying UDI/DI 08436046001114, serial numbers G24948, G25512, C25673, 25901, G25771, G26990, G25506, G22189 and G30240, 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-Batt; 40KW ANALOG, Mobile X-ray system
- Manufacturer
- SEDECAL SA
- Category
- Medical Device — Mobile X-ray
- Affected units
- 9
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 (10)
- UDI/DI 08436046001114
- Serial Numbers: G24948
- G25512
- C25673
- 25901
- G25771
- G26990
- G25506
- G22189
- G30240.
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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