SEDECAL SA recalled its Mobile X-ray system on June 10, 2025, due to a water resistance hazard. The company alerted users to strictly follow cleaning instructions to avoid potential harm. The recall affects devices 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 recall involves the Mobile X-ray system by SEDECAL SA. Specific models include UDI/DI unknown and Serial Numbers: 40116. The devices were distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant. Improper cleaning may lead to equipment malfunction or failure.
No incidents or injuries have been reported related to this recall. The potential risks stem from improper cleaning practices.
Stop using the Mobile X-ray system immediately. Follow the recall instructions provided via email from SEDECAL SA.
For further instructions, contact SEDECAL SA or your healthcare provider. More information can be found at the FDA recall page.
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