—#208204

Product

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

FDA product code: KQM — Camera, Surgical And Accessories
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected 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, 108817693, 108817694, 108823304, 108826291, 108826292, 108826293, 108826294, 108826295, 108826296, 108832044, 108835017, 108835018, 108835019, 108835020, 108835100, 108835102, 108835103, 108877191, 108877192, 108886196, 108886197, 108886204, 108886205, 108886206, 108886207, 108886208, 108886209, 108891278, 108892971, 108896990, 108909639, 108909640, 108914098, 108914100, 108917065, 108917882, 108917883, 108917891, 108917892, 108917893, 108917894, 108926822, 108926823, 108927498, 108927506, 108927508, 108927509, 108927511, 108938126, 108938128, 108938130, 108952802, 108952803, 108952804, 108952805, 108954128, 108957452, 108957453, 108957454, 108957455, 108959400, 108959401, 108959402, 108959403, 108959404, 108959405, 108961409, 108961410, 108961411, 108961412, 108965179, 108965180, 108965181, 108965182, 108965183, 108970447, 108970448, 108970449, 108970450, 108970451, 108970452, 108970455, 108970456, 108970457, 108973043, 109042912, 109042913, 109042914, 109042915, 109042916, 109042917, 109042918, 109042919, 109042920, 109042921, 109042922, 109042923; c) UDI/DI 00887761968455, Serial Numbers: 108592036, 108611920, 108619324, 108648397, 108648399, 108653145, 108664152, 108665620, 108671478, 108671479, 108671488, 108757703, 108778413, 108784863, 108832046, 108832147, 108835101, 108892991, 108896993, 108896994, 108917886, 108917889, 108933948, 108933952, 108933958, 108941393, 108941394, 108941395, 108941397, 108949663, 108949664, 108949665, 108949666, 108949667, 108949668, 108966760, 108966761, 108966762, 108966763, 108966764, 108966765, 108966766, 108966767, 108973046, 108973047, 108973048, 108973049, 108978929, 108982386, 108982387

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Baxter issued an Urgent Medical Device Correction notice to its consignees on 06/04/2024 via US mail, first class. The notice explained the issue with the devices, potential hazards involved, and requested the following: "Actions to be Taken by Customers: 1. Operators may continue to use the iLED 7 surgical light systems by following the current instructions for use (IFU) cautions and warnings while considering the additional information below. . Utilize the lowest possible illumination level suitable for the procedure, especially in certain neurological or intestinal procedures on delicate, thin, dry, or abnormal tissue. . Avoid overlapping light fields that are set at high intensity (80% or higher). - If the light intensity of one light-head is set at 80% or higher the second light-head, if overlapping, should be set at 50% or lower. - If the light intensity of two or more light heads is set at 80% or higher, to minimize risk do not overlap them. . If a very high-intensity setting is temporarily required, reduce intensity as soon as the need passes. . Ensure the Adaptive Light Control (ALC) Plus sensor is activated and indicated on the wall or mobile control panel. If activation of the ALC Plus is not possible, please contact a technical service representative for further instructions. . If the ALC Plus is switched off, the light-head needs to be positioned at 100 centimeters (39.37 inches) from the surgical field. At other distances the illuminance and irradiance limits can be exceeded, which may result in thermal skin injuries. 2. Additional safety information reviewing the potential risks of using an overhead surgical light, including educational safety content is available through Pfiedler education (a division of AORN) at the URL listed below. This website requires a one-time registration. https://www.pfiedlereducation.com/diweb/gateway/f/https*3A*2F*2Fwww.pfi edlereducation.com*2Fdiweb*2Fcatalog*2Fitem*2Feid*2F1552-2024. " The notice also requested tha

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-06-04
Posted by FDA: 2024-07-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208204. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.