SEDECAL SA recalled six units of its Mobile X-ray system on June 10, 2025. The device is not water-resistant and improper cleaning can lead to hazards. Healthcare providers must stop using the device 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
The recalled product is the Mobile X-ray system, model number SM-40HF-B-D-C; 40KW 80C. It was distributed in California, Illinois, and New Jersey. Six units were recalled.
The Mobile X-ray system is not water-resistant. Improper cleaning can lead to malfunctions and potential risks for patients and healthcare providers.
No specific incidents have been reported related to injuries or malfunctions from this device. The recall is precautionary.
Stop using the Mobile X-ray system immediately. Contact SEDECAL SA or your healthcare provider for further instructions.
For more information, contact SEDECAL SA via the email provided in the recall notification. Visit the FDA link for further updates.
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