medical Class II Updated 2020-06-10

Intuitive Surgical, Inc. recalls da Vinci SP surgical system

Recalled Product

da Vinci SP surgical system


Hazard / Issue

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.

Issued by

FDA

Affected States: OH, NY, MN, TN, TX, OR, IL, MD, NJ, AL
Lot/Code Info: Serial Numbers: SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, SP0030
View official government recall

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