Intuitive Surgical, Inc.: Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product

Hazard

Due to increased complaints for broken/frayed grip cables for reusable instruments.

Details from the source

Reason for recall: Due to increased complaints for broken/frayed grip cables for reusable instruments. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federat Quantity: 7819 Lot/code info: Lot Code: 420194, Mega Needle Driver GTIN: 00886874111611 FDA Medical Device Listing Number: D088920 Material Number: 420194-08 Batch / System Numbers: M10120201 SH1182 M20120412 SH1182 M10130121 SH1570 M10130306 SH1570 M10110602 SH0547 M10110627 SH0547 M10121129 SH0059 M10121214 SH0059 M10130429 SH0059 M10130521 SH0059 M10121105 SH1557 M10130517 SH1837 M10121109 SH1390 M10130508 SH1390 M10131004 SH1390 M10130306 USG689 M10130412 USG689 M10110302 SH1368 M10110614 SH1368 M10110620 SH1368 M10110817 SH1368 M10120705 SH1368 M10121022 SH1368 M10130429 SH1368 M10130509 SH1368 M10130722 SH1368 M10110131 USG294 M10110511 USG294 M10110616 USG294 M10110811 USG294 M10111003 USG294 M20111103 USG294 M10111206 USG294 M20120103 USG294 M10120130 USG294 M10120305 USG294 M10120425 USG294 M10120713 USG294 M10121004 USG294 M10121017 USG294 M10121022 USG294 M10121105 USG294 M10121107 USG294 M10121206 USG294 M10121207 USG294 M10130108 USG294 M10130112 USG294 M10130201 USG294 M10130213 USG294 M10130215 USG294 M10130529 USG294 M11130608 USG294 M10130718 USG294 M10130829 USG294 M10120321 SG2026 M10120605 SG2026 M10111114 SH0825 M10110330 SH0935 M10110401 SH0935 M10120123 SH0935 M10120313 SH0935 M10120404 SH0935 M10120802 SH0935 M10120919 SH0935 M10121121 SH0935 M10110302 SH0729 M10110503 SH0729 M10110701 SH0729 M10110809 SH0729 M10110817 SH0729 M10110825 SH0729 M10110913 SH0729 M10110923 SH0729 M10111116 SH0729 M20111123 SH0729 M10111201 SH0729 M10120120 SH0729 M10120130 SH0729 M10120210 SH0729 M1012

UPC codes

00886874111611

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.