FDA-Device2025-10-29Class IIMISBRANDING
Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
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.
Who it affects
Adults
Illnesses reported
None reported
Sold states
US: CA, IL, and NJ
Affected count
22 units
Manufactured in
Pelaya, 9 Pol., Pol. Ind. Rio De Janeiro, Algete, Spain
Products
Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0256-2026Don't want to check this manually?
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