Z-2313-2024Class II

VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical...

Name: Z-2313-2024 VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical...
Creator: Baxter Healthcare Corporation
Published: 2024-06-04
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-06-04 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c)... on 2024-06-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2313-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-04
Posted: 2024-07-05
Recalling firm: Baxter Healthcare Corporation
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)
Product code: KQM Camera, Surgical And Accessories
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
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 275 units
Distribution: Worldwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2313-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2313-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-05
Z-2314-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-05
Z-2315-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-05

Product code KQM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)