Easy Moving Plus X-ray systems recalled with water resistance reminder
Sedecal is recalling eight Easy Moving Plus SM-50HF-B-D-C 50KW 50G 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 Easy Moving Plus mobile X-ray system, model SM-50HF-B-D-C (50KW 50G), 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 eight units carrying UDI/DI 08436046001527, with serial numbers including 151248, G23340, C05006-W, G22215, 7034, G25402 and G25910, 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
- Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, 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 (9)
- UDI/DI 08436046001527
- Serial Numbers: 151248
- G23340
- C05006-W
- G22215
- G27497/584
- 7034
- G25402
- G25910.
Distribution
Distributed in 3 states:
- CA
- IL
- NJ
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