SEDECAL SA: 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.

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: 22 units Lot/code info: UDI/DI 08436046001466, Serial Numbers: G-33344, G29404, G29407, G30258, G30236, G63124, G60169, G26234, G26284, G25734, G38069, G-40590, G41143, G62020, G69393, G38082, G41163, G60166, G26244, G40196, G60461, G33309.

UPC codes

08436046001466

Source

Official record: FDA (Device enforcement) ↗

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