FDA-Device2025-10-29Class IIMISBRANDING
Sedecal 40KW-FX.899 mobile X-ray system requires proper cleaning to prevent water damage
What this means
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
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
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-0245-2026Want us to check the next one for you?
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