Battery analog 32KW X-ray systems recalled with water resistance reminder
Sedecal is recalling 22 SM-32HF-Batt 32KW 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-32HF-Batt (32KW 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 22 units carrying UDI/DI 08436046001466, with serial numbers including G-33344, G29404, G29407, G30258, G30236, G63124, G60169, G26234 and G26284, 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 SM-32HF-Batt; 32KW ANALOG, 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 (20)
- UDI/DI 08436046001466
- Serial Numbers: G-33344
- G29404
- G29407
- G30258
- G30236
- G63124
- G60169
- G26234
- G26284
- G25734
- G38069
- G-40590
- G41143
- G62020
- G69393
- G38082
- G41163
- G60166
- G26244
Distribution
Distributed in 3 states:
- CA
- IL
- NJ
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