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FDA (Device enforcement)Recalled 2025-06-10class ii

SEDECAL SA: 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.

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: 27 units Lot/code info: 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.

Source

Official record: FDA (Device enforcement)

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

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