Baxter VidiaPort and Trulight surgical lights recalled for thermal burn risk
Baxter Healthcare Corporation is recalling VidiaPort and Trulight surgical light systems due to customer reports of thermal skin injuries. Approximately 275 units were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall with documented reports of thermal skin injuries occurring during use. The reported injuries qualify as significant injury reports meeting the Severe classification criterion.
Plain-English summary
Baxter Healthcare Corporation is recalling VidiaPort carrying arm units (models 4028110, 4028210, and 4028310) and Trulight surgical light products equipped with iLED 7 light-heads. Approximately 275 units have been distributed worldwide.
The recall follows customer reports of thermal skin injuries occurring during use of these surgical light systems. The company issued an urgent medical device correction to address this safety issue.
Healthcare facilities that operate surgical light systems should verify whether they have affected units by checking the model numbers and serial numbers against the recall list. Affected units can be identified by the specific serial numbers provided in the recall notice.
Facilities with affected equipment should contact Baxter Healthcare Corporation for instructions on the proper handling and remediation of these devices.
The recalled product
- 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)
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Surgical Lights
- Hazard
- Affected units
- 275
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 (20)
- 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
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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