FDA-Device2025-10-29Class IIMISBRANDING
Sedecal 40KWFX mobile X-ray system requires proper cleaning to prevent equipment damage
What this means
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
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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-0244-2026Want us to check the next one for you?
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