da Vinci SP surgical system
Published June 10, 2020 · Recall initiated: April 1, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: South Korea
- Lot
- Serial Numbers: SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, SP0030
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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