SEDECAL SA recalled 12 units of its Mobile X-ray system on June 10, 2025, due to water resistance issues. Users must adhere to strict cleaning instructions to avoid equipment damage. The recall affects units distributed in California, Illinois, and New Jersey.
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 product is the Model Number 40KWFXPLUS.005 Mobile X-ray system. It has model numbers including UDI/DI 08436046002166 and serial numbers such as G82576, G82871, and G78884. The units were distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant, posing a risk of malfunction if cleaned improperly. Failure to follow the cleaning instructions can lead to equipment failure.
There are no reported injuries or incidents associated with this recall. However, the importance of proper cleaning and maintenance is emphasized.
Stop using the Mobile X-ray system immediately. Follow the recall instructions provided by Sedecal. Contact SEDECAL SA or your healthcare provider for further instructions.
For more information, visit the SEDECAL website or contact your healthcare provider. Additional details can be found at the FDA recall page.
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