FDA-Device2025-10-29Class IIPROCESSING DEFECT
Sedecal MobileDiagnost wDR 2.2 mobile X-ray system water damage reminder
ELECTRICAL SHOCKOTHERNationwide distribution
Follow cleaning instructions for Sedecal X-ray equipment
Sedecal is reminding users that the MobileDiagnost wDR 2.2 mobile X-ray system is not water-resistant. Improper cleaning can damage the equipment and may affect its safety and performance. Users must follow the cleaning instructions in the equipment manual.
- Review your equipment's manual for the correct cleaning procedures
- Do not use water or moisture-based cleaners unless specified in the manual
- Contact Sedecal if you are unsure about proper cleaning methods
- If your equipment has been improperly cleaned, contact a service representative
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
1198 units
Manufactured in
Pelaya, 9 Pol., Pol. Ind. Rio De Janeiro, Algete, Spain
Products
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0243-2026Don't want to check this manually?
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