FDA-Device2025-10-29Class IIPROCESSING DEFECT
Sedecal MobileDiagnost wDR 2.2 mobile X-ray system water damage reminder
What this means
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
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
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-0243-2026Want us to check the next one for you?
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