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)
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Baxter Healthcare Corporation
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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)
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2313-2024
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