Baxter Healthcare Corporation: VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ce

Hazard

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads

Details from the source

Reason for recall: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads Distribution: Worldwide distribution. Quantity: 275 units Lot/code info: a) UDI/DI 00887761968523, Serial Numbers: 108664155, 108664156, 108669683, 108669684, 108673461, 108696617, 108726885, 108731089, 108746956, 108754496, 108754497, 108821898, 108835099, 108907603, 108909646, 108917888, 108919439, 108919440, 108919441, 108961413, 108961414, 108970453, 108970454; b) UDI/DI 00887761968462, Serial Numbers: 108645027, 108645028, 108645031, 108648403, 108652874, 108664909, 108664911, 108665618, 108669680, 108669681, 108669682, 108671489, 108671494, 108671495, 108671496, 108671497, 108671498, 108671499, 108671500, 108674055, 108674056, 108674057, 108674058, 108676619, 108676620, 108676621, 108677352, 108677353, 108678974, 108678975, 108680874, 108680875, 108680877, 108683306, 108692868, 108696905, 108698871, 108712900, 108713005, 108724511, 108724512, 108726889, 108726890, 108726969, 108726970, 108729819, 108729820, 108729821, 108729822, 108740036, 108740037, 108741241, 108741242, 108741243, 108741244, 108741245, 108741246, 108746957, 108746958, 108750621, 108750622, 108750623, 108750624, 108750625, 108753175, 108753176, 108753177, 108753178, 108753179, 108766308, 108766309, 108766310, 108766311, 108768265, 108773362, 108773388, 108773389, 108776596, 108776597, 108776598, 108776599, 108784862, 108784865, 108784866, 108784867, 108784868, 108786548, 108786549, 108786550, 108786551, 108786552, 108786553, 108798264, 108799126, 108799128, 108799129, 108799130, 108799131, 108799132, 108799133, 108806749, 108806750, 108806751, 108806752, 108817691, 10881769

UPC codes

00887761968523, 00887761968462, 00887761968455

Source

Official record: FDA (Device enforcement) ↗

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