Z-2260-2020 Class II Terminated
FDA device recall Z-2260-2020 was initiated by Intuitive Surgical, Inc. on April 1, 2019 and is designated Class II. 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 un… The recall status is terminated (terminated December 16, 2021). Affected quantity: 17.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- April 1, 2019
- Termination Date
- December 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17
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.
Distribution Pattern
U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: South Korea
Code Information
Serial Numbers: SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, SP0030