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SurgiLight Disposable Handle Assembly
BihlerMed, L.L.C. · Model 2816-01-0002 · UDI-DI 10865082000174
FTA
Prescription
10
510(k) clearances
373
Adverse events
5
Recalls
89
Facilities
Description
The Disposable Handle Assembly is a sub-assembly of the View Medical SurgiLight. The Disposable Handle Assembly attaches to the SurgiLight and is essential to the overall functionality of the surgical light. The dual purpose handle gives the user the ability to focus the light by rotating the handle and serves as a layer of protection for the light-emitting diode (LED) housing. The medical cover sleeve is extended over the SurgiLight to provide a sterile barrier to the flexible shaft.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-17 | Steris Corporation | Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result i |
| 2023-03-17 | Steris Corporation | Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result i |
| 2017-10-13 | Ecolab, Inc. | Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. |
| 2007-02-13 | Sunnex Inc. | Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder. |
| 2007-02-13 | Sunnex Inc. | Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.