SEDECAL SA recalled eight mobile X-ray systems on June 10, 2025. The recall follows warnings that the devices are not water-resistant and must be cleaned per the manual. Users must stop using the device immediately to avoid potential injuries.
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 Mobile X-ray system, model number SM-32HF-B-D-C. Eight units were distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant, posing a risk of electrical hazards if not cleaned properly. Improper cleaning can lead to equipment malfunction.
No incidents or injuries have been reported related to this recall. However, improper cleaning may pose risks to users.
Stop using the device immediately. Follow the manufacturer's recall instructions and contact SEDECAL SA or your healthcare provider for further guidance.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0255-2026.
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