8MM,FORCE BIPOLAR,IS4000 REF 471405
Reported: January 22, 2025 Initiated: December 19, 2024 #Z-0883-2025
Product Description
8MM,FORCE BIPOLAR,IS4000 REF 471405
Reason for Recall
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 46,759
- Distribution
- U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
8MM,FORCE BIPOLAR,IS4000 REF 471405. Recalled by Intuitive Surgical, Inc.. Units affected: 46,759.
Why was this product recalled? ▼
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0883-2025.
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