Intuitive Surgical product recalled over fire hazard

Recall date

September 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Intuitive Surgical, Inc. recalls Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156…

Recall number

Z-2782-2015

FDA classification

Class II

Brand / firm

Intuitive Surgical, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.