da Vinci Xi Surgical System
Reported: May 20, 2020 Initiated: November 21, 2018 #Z-1960-2020
Product Description
da Vinci Xi Surgical System
Reason for Recall
Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 74 USMs containing affected rotors.
- Distribution
- U.S.: CA, MD, NY, VA, IL, MI, DE, TX, FL, NJ, MA, KY and OH. O.U.S.: Australia, France, Germany and Japan.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
da Vinci Xi Surgical System. Recalled by Intuitive Surgical, Inc.. Units affected: 74 USMs containing affected rotors..
Why was this product recalled? ▼
Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2020. Severity: Moderate. Recall number: Z-1960-2020.
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