Sedecal recalled eight units of its Easy Moving Plus Mobile X-ray system on June 10, 2025. The recall follows warnings that the equipment is not water-resistant and improper cleaning can lead to serious consequences. Users must stop using the device immediately and follow the manufacturer's 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
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The recalled model is the Sedecal Easy Moving Plus, Model Number SM-50HF-B-D-C, with UDI/DI 08436046001527. Eight units were distributed in California, Illinois, and New Jersey.
The device is not water-resistant, and improper cleaning can lead to electrical hazards and malfunction. Users must adhere strictly to the cleaning instructions provided in the manual.
There have been no reported incidents, injuries, or deaths associated with this recall. However, improper cleaning poses a high risk to users and patients.
Stop using the device immediately. Follow the recall instructions provided by Sedecal. Contact SEDECAL SA or your healthcare provider for further instructions.
For more information, contact SEDECAL SA via email or visit their website. Further details can be found at the FDA recall page.
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