Sedecal recalled 142 units of its SM-40HF-B-D-C Mobile X-ray system on June 10, 2025. The equipment is not water-resistant and requires strict cleaning protocols to prevent hazards. Improper cleaning can lead to potentially dangerous consequences for 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
The recall affects model number SM-40HF-B-D-C, a 40KW Mobile X-ray system. It was distributed in California, Illinois, and New Jersey. The recall includes 142 units.
The Mobile X-ray system is not water-resistant. Improper cleaning can lead to equipment failure and potential safety risks for users.
No specific incidents, injuries, or deaths have been reported related to this recall. The hazard level is classified as high due to the potential consequences of improper cleaning.
Stop using the Mobile X-ray system immediately. Follow the cleaning instructions provided in the user manual. 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-0277-2026.
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