FDA-Device2025-10-29Class IIMISBRANDING
Sedecal 40KWFX mobile X-ray system requires proper cleaning to prevent equipment damage
Follow Sedecal X-ray cleaning instructions carefully
Sedecal reminded users that its 40KWFX mobile X-ray systems are not water-resistant and must be cleaned strictly according to the manual instructions. Improper cleaning could damage the equipment. This notice affects 55 units distributed in California, Illinois, and New Jersey.
- Review the cleaning instructions in your 40KWFX manual
- Do not use water-resistant or excessive water-based cleaning methods
- Follow only the manufacturer's approved cleaning procedures
- Contact Sedecal if you have questions about proper maintenance
Hazard
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.
Sold states
US: CA, IL, and NJ
Affected count
55 units
Manufactured in
Pelaya, 9 Pol., Pol. Ind. Rio De Janeiro, Algete, Spain
Products
Model Number 40KWFX, Mobile X-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0244-2026Don't want to check this manually?
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