da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Reported: April 5, 2023 Initiated: February 10, 2023 #Z-1293-2023
Product Description
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Reason for Recall
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 1,225 total USMs
- Distribution
- U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, Indonesia, Israel, Italy, Kuwait, Lebanon, Malaysia, Malta, Mexico, New Zealand, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Thailand, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200. Recalled by Intuitive Surgical, Inc.. Units affected: 1,225 total USMs.
Why was this product recalled? ▼
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2023. Severity: Moderate. Recall number: Z-1293-2023.
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