SEDECAL SA recalled 17 units of its Mobile X-ray system on June 10, 2025. The equipment is not water-resistant, posing a risk if not cleaned per manual instructions. Healthcare providers must stop using the device immediately.
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 Mobile X-ray system includes models with UDI/DI 08436046002166 and serial numbers G86476, G86632, G86634, G85447, G86619, G85453, G85461, G86477, G86633, G87334, G87335, G87336, G87353, G86617, G87337, G85335, and G85452. The devices were distributed in California, Illinois, and New Jersey.
This device is not water-resistant. Improper cleaning can lead to equipment failure or safety hazards.
There are no reported injuries or incidents associated with this recall. The potential risk remains high due to improper cleaning.
Stop using the Mobile X-ray system immediately. Follow the recall instructions provided by the manufacturer and contact SEDECAL SA or a healthcare provider for further guidance.
For more information, contact SEDECAL SA at their official website or follow the notification method via email.
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