Reported Jul 8, 2015 · Terminated
INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope…
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?
- INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
- Lot codes and dates
- Manufacturing lot numbers
470015-05470015-06
- System numbers
310 of 310 codes
SK0194SK0312SK0182SK0195SK0313SK0241SK0321SK0131SK0117SK0149SK0068SK0197SK0329SK0185SK0183SK0253SK0142SK0141SK0078SK0128SK0224SK0192SK0381SK0085SK0086SK0247SK0109SK0088SK0199SK0200SK0201SK0215SK0223SK0336SK0164SK0256SK0202SK0214SK0089SK0165SK0374SK0374SK0124SK0260SK0323SK0252SK0319SK0327SK0373SK0335SK0129SK0184SK0229SK0110SK0111SK0350SK0351SK0136SK0132SK0190
- Manufacturing lot numbers
- Amount recalled
- 310
Where it was sold
- Nationwide
- PR
Why it was recalled
Field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi Drapes and Xi instruments. A pinched drape may cause a message on the Vision Cart touchscreen - Missing reload error.
This product could cause temporary or reversible health problems — stop using it.
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