FDA-Device2025-10-29Class IIMISBRANDING
Sedecal 40KW-FX.899 mobile X-ray system requires proper cleaning to prevent water damage
Follow Sedecal X-ray cleaning instructions carefully
Sedecal notified users that the Model 40KW-FX.899 mobile X-ray system is not water-resistant and must be cleaned exactly according to the manual instructions. Improper cleaning could damage the equipment.
- Review the cleaning instructions in your equipment manual carefully
- Clean only using the methods specified in the manual
- Contact Sedecal if you have questions about proper cleaning
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
1 unit
Manufactured in
Pelaya, 9 Pol., Pol. Ind. Rio De Janeiro, Algete, Spain
Products
Model Number 40KW-FX.899, Mobile X-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0245-2026Don't want to check this manually?
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