FDAFDA · Food and drugs·Recall number Z-0447-2015
8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Published December 3, 2014 · Recall initiated: November 3, 2014
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
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
- Lot
- Part number; 470344-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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