Sedecal SA recalled 8 mobile X-ray units in the United States after notifying consignees that the equipment is not water-resistant and must be cleaned strictly per the manual. The notice warns that improper cleaning could have consequences described in the manual. Healthcare providers and patients should stop using the devices immediately and contact Sedecal SA or their healthcare provider for the
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 Sedecal 40KWFXPLUS.002 is a mobile X-ray imaging system used in clinics and hospitals to perform radiographs at patient bedsides.
The device is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could lead to equipment damage or unsafe conditions as described by the manufacturer.
This recall is not identified as part of a broader industry pattern.
Immediate use of the affected devices is not advised, which could affect patient care workflows and require reallocation of imaging resources.
Device label, manual, and the FDA recall page (Z-0247-2026).
4-8 weeks for refunds or replacements under typical recall handling.
Save recall emails, keep serial numbers, photos of labels, and all communications with Sedecal SA or healthcare providers.
Model Number 40KWFXPLUS.002. Mobile X-ray system. Eight units distributed in the United States in California, Illinois, and New Jersey.
No injuries or incidents have been reported.
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