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TL 5000/3000 – Surgical Light recallZ-2314-2024 · Baxter Healthcare Corporation · initiated Jun 4, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-2314-2024
Status
Open, Classified
Initiated by the company
Jun 4, 2024
Posted by the FDA
Jul 5, 2024
Recalling firm
Baxter Healthcare Corporation
Quantity
5 units
Product code
FTD
Distribution
Worldwide distribution.

Product description

Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)

Code information (models, lots, serial numbers)

a) UDI/DI 00887761968400, Serial Numbers: 107565745; b) UDI/DI 00887761968394, Serial Numbers: 107565746, 107592673, 107592675, 108034069

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94766).

Sources and updates

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