SEDECAL SA recalled one Mobile X-ray system on June 10, 2025, due to improper cleaning instructions. The device is not water-resistant, posing a potential hazard for users. This recall serves as a reminder to follow all cleaning protocols strictly to avoid consequences.
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
The recalled product is the Mobile X-ray system, Model Number SM-40HF-B-D-C; 40KW 55C. It was distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant and must be cleaned according to the instructions in the manual. Improper cleaning can lead to equipment failure or safety hazards.
No specific incidents or injuries were reported related to this recall. The hazard classification is marked as Class II, indicating a moderate risk.
Patients and healthcare providers should stop using the Mobile X-ray system immediately. Follow the recall instructions provided by SEDECAL SA and contact your healthcare provider for further guidance.
For more information, contact SEDECAL SA or visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0259-2026.
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