Reported Jul 17, 2024 · Ongoing

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

Baxter Healthcare Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • Trulight 5000/3000 Surgical Light
  • model numbers
    • a) 4038210 (Duo Surgical Lights}
    • b) 4038310 (Trio/Quad Surgical Lights)
Lot codes and dates
  • a) UDI/DI 00887761968400
  • Serial Numbers
    • 107565745
    • b) UDI/DI 00887761968394
  • Serial Numbers
    • 107565746
    • 107592673
    • 107592675
    • 108034069
Amount recalled
5 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.