SEDECAL SA
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
UDI/DI unknown, Serial Numbers:G31761, G30761, G32587, G32577, G31065, G33581, G30808, G30762, G29873, G30156, G30173, G30952, G30689, G33004, G30155, G30025, G35450, G35620, G30570, G31077, G29426, G33144, G29416, G30160, G30685, G33723, G30165.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →