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 70C READY, Mobile X-ray system
UDI/DI 08436046001510, Serial Numbers: G37158, G61698, G62863, G41192, G62814, G41098, G62566, G60400, G63392, G60406.
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 →