da Vinci SP surgical system
Reported: June 10, 2020 Initiated: April 1, 2019 #Z-2260-2020
Product Description
da Vinci SP surgical system
Reason for Recall
Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 17
- Distribution
- U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: South Korea
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
da Vinci SP surgical system. Recalled by Intuitive Surgical, Inc.. Units affected: 17.
Why was this product recalled? ▼
Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 10, 2020. Severity: Moderate. Recall number: Z-2260-2020.
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