SEDECAL SA recalled one unit of its Model SM-40HF-B-D-C Mobile X-ray system on June 10, 2025. The recall follows concerns that improper cleaning may lead to equipment failure. Users in California, Illinois, and New Jersey received an email warning regarding the device's lack of water resistance.
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 SM-40HF-B-D-C Mobile X-ray system, UDI/DI 08436046001510, Serial Number G37587. It was distributed in California, Illinois, and New Jersey.
The equipment is not water-resistant. Improper cleaning can lead to serious equipment malfunction and potential risks to patient safety.
There are no reported incidents or injuries at this time. The company issued the recall proactively to mitigate risks.
Stop using the device immediately. Follow the cleaning instructions provided by the manufacturer to avoid hazards.
For further instructions, contact SEDECAL SA or your healthcare provider. Visit the FDA recall page for more information.
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