SEDECAL SA recalled 14 units of its SM-40HF-B-D-C mobile X-ray system on June 10, 2025. The company warned that the device is not water-resistant and improper cleaning can lead to serious consequences. Health care providers must stop using the equipment immediately and follow recall instructions.
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 recalled product is the SM-40HF-B-D-C mobile X-ray system, UDI/DI 08436046001510. It was distributed across California, Illinois, and New Jersey. The recall affects 14 units.
The mobile X-ray system is not water-resistant. Improper cleaning can lead to equipment malfunction or unsafe conditions for patients.
No specific incidents have been reported related to this recall. Users are advised to adhere strictly to the cleaning instructions.
Stop using the mobile X-ray system immediately. Contact SEDECAL SA or your healthcare provider for further instructions on returning the product.
For further inquiries, visit the SEDECAL SA website or the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0260-2026.
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