FDA-Device2025-10-29Class IIPROCESSING DEFECT
Model Number SM-40HF-B-D-C; 40KW 50G, 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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US: CA, IL, and NJ
Affected count
27 units
Manufactured in
Pelaya, 9 Pol., Pol. Ind. Rio De Janeiro, Algete, Spain
Products
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0264-2026Want us to check the next one for you?
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