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Recall Observatory FDA recall evidence

Device product

da Vinci SP surgical system

Z-2260-2020

April 01, 2019

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 85293
Status
Terminated
Classification
Class II
Quantity
17
Official record key
device-enforcement:Z-2260-2020

Official wording

Reason: 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.

Code information: Serial Numbers: SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, SP0030

Distribution pattern: U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: South Korea

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software anomaly. This issue