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Intuitive Surgical, Inc. Recall 90332

Description: Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003

Intuitive Surgical, Inc. Recall 90332 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1459-2022
Event ID90332
Event DescriptionDa Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
Product TypeDevices
DistributionWorldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Quantity62,895 Clip appliers
Recall ReasonDue to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Device Classification20220803
Device Code InfoModel/Model Number/UDI Number Da Vinci S/Si Large Clip Applier / 420230 / 00886874111680 Da Vinci S/Si Medium-Large Clip Applier / 420327 / 00886874111826 Da Vinci S/Si Small Clip Applier / 420003 / 00886874111161 Serial Numbers: All
Center Classification Date20220725
Recall Initiation Date20220701
Recalling FirmIntuitive Surgical, Inc.
Initial Notification Letter
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