SEDECAL SA: Model SM-40HF-B-D-C; 40KW 70C, 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.

Details from the source

Reason for recall: 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. Distribution: US: CA, IL, and NJ Quantity: 14 units Lot/code info: UDI/DI 08436046001510, Serial Numbers: G13768, G36626, G62493, G39518, G61725, G36211, G36281, G36573, G36581, G61368, G61880, G62037, G61367, G36227.

UPC codes

08436046001510

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.