Sedecal recalled 39 units of its Mobile X-ray system on June 10, 2025. The device is not water-resistant and may pose a hazard if improperly cleaned. Users must follow specific cleaning instructions to avoid potential risks.
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 Mobile X-ray system, model SM-40HF-B-D-C, includes various serial numbers such as G25456, G25508, and G25681. It was distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant and improper cleaning can lead to electrical hazards. Users must adhere strictly to the cleaning manual to mitigate risks.
No injuries or deaths have been reported related to this recall. The recall is classified as Class II, indicating a potential risk of serious injury.
Stop using the device immediately. Follow the instructions provided in the recall email from Sedecal and contact your healthcare provider for further guidance.
For more information, contact SEDECAL SA or visit the following link: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0258-2026.
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