Sedecal SA recalls a single SM-20HF-Batt 20KW analog mobile X-ray system distributed in the United States and Canada after notifying consignees via email. The device is not water-resistant and must be cleaned strictly as described in the manual. Improper cleaning could cause safety or equipment issues.
Sedecal sent an email to its consignees to remind the 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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEDECAL SA or your healthcare provider for instructions. Notification method: E-Mail
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The SM-20HF-Batt is a portable, 20KW analog mobile X-ray system used in clinical settings for radiography. Hospitals and clinics rely on such systems for bedside imaging.
The recall centers on the device not being water-resistant and the need to clean it exactly as described in the manual. Improper cleaning could compromise safety or equipment integrity.
This recall is not described as part of a broader industry pattern.
Facilities with the device should halt use and review cleaning procedures to avoid potential damage or injury. The action is primarily operational and safety-focused rather than indicating current patient harm.
Identifiers are on the device label and in the recall notice. UDI/DI is 08436046001091; Serial Number is G23218.
Remediation processing may take 4-8 weeks for refunds or replacements.
Save recall notices, document serial/UDI numbers, take photos of labels, keep all email communications and hospital risk management notes.
Model numbers: SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system. Sold in the United States (CA, IL, NJ) and Canada. Recall date: 2025-06-10. Price: Unknown.
No injuries or incidents have been reported.
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