Sedecal recalled two units of its Mobile X-ray system on June 10, 2025. Users must stop using the device due to improper cleaning risks. The equipment is not water-resistant, posing a high hazard to patients and healthcare providers.
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 model is SM-40HF-B-D-C; 40KW 55G/60G. The devices were distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant. Improper cleaning can lead to equipment failure and potential harm to users.
No specific incidents have been reported. The high hazard level indicates significant risk without reported injuries.
Stop using the Mobile X-ray system immediately. Contact SEDECAL SA or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0268-2026.
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