FDAFDA · Food and drugs·Recall number Z-0898-2018
Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
Published March 14, 2018 · Recall initiated: September 22, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
- Lot
- Serial Number: 20509715, 20465096, 20503137, 20520960, 20541967, 20546219, 20546440, 20575512, and 20575518.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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