Reported Jul 9, 2014 · Terminated
Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 100 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
- Lot codes and dates
Part number 551184 - US ManualPart number 550965 - OUs manuals
- Amount recalled
- All distributed prior to June 2014
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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