Baxter Trulight Surgical Lights Recalled for Thermal Skin Injuries
Baxter Healthcare Corporation recalled Trulight 5000/3000 Surgical Light systems due to customer reports of thermal skin injuries. The urgent medical device correction affects models 4038210 and 4038310 distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: Customer reports of thermal skin injuries from a Class II medical device meet the rubric criterion for Severe severity: significant injury/property-damage reports on Class II devices.
Plain-English summary
Baxter Healthcare Corporation has issued an urgent medical device correction for Trulight 5000/3000 Surgical Light systems. The recall affects model numbers 4038210 (Duo Surgical Lights) and 4038310 (Trio/Quad Surgical Lights), as well as VidiaPort and Trulight product codes equipped with iLED 7 light-head systems.
The correction was issued following customer reports of thermal skin injuries during use of these surgical light systems. Thermal injuries represent a significant safety concern in the operating room environment.
The affected units have been distributed worldwide. Specific serial numbers have been provided to assist with identification of the impacted devices.
Healthcare facilities currently using these devices should contact Baxter Healthcare Corporation regarding the urgent correction and any necessary remediation measures.
The recalled product
- Product
- Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- thermal-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- a) UDI/DI 00887761968400
- Serial Numbers: 107565745
- b) UDI/DI 00887761968394
- Serial Numbers: 107565746
- 107592673
- 107592675
- 108034069
Distribution
Distribution scope not specified by the agency.
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