SEDECAL SA recalled six units of its Mobile X-ray system on June 10, 2025, due to improper cleaning risks. The equipment is not water-resistant, posing a potential hazard if not maintained according to the manual. Users must stop using the device immediately and follow recall instructions.
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 recalled models are SM-40HF-B-D-C and 40KW.002. The affected serial numbers include G39544, G62558, G71736, G40116, G65568, and G65570. These units were distributed in California, Illinois, and New Jersey.
The Mobile X-ray system is not water-resistant. Improper cleaning can lead to equipment malfunction, posing serious risks to patients and healthcare providers.
There are no reported injuries or incidents associated with this recall. Users have been reminded of the importance of following cleaning instructions to prevent potential hazards.
Stop using the Mobile X-ray system immediately. Follow the instructions provided in the recall notice from SEDECAL SA. Contact your healthcare provider for further guidance.
For more information, contact SEDECAL SA or visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0278-2026.
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