The FDA announced on April 1, 2019, that Intuitive Surgical, Inc. is recalling its da Vinci SP surgical system due to a software anomaly that may trigger mechanical vibration of instrument tips and the endoscope. The agency issued recall number Z-2260-2020 for the Class II device.
How to tell if you have it
- Brand: Intuitive Surgical
- Product: da Vinci SP surgical system
- Serial Numbers: SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, SP0030
The hazard
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 extremely rare specific conditions: when the user is activating Adjust Mode, the instrument Arm is near its vertical position limit, and the user is applying sustained force against the hand control haptic feedback.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since June 1, 2017. Other recent recalls of similar products include Da Vinci 5 dV5 Tower NIR Handheld Camera Recall (April 24, 2026), Intuitive Surgical Da Vinci Surgical System Recall (April 22, 2026), and Da Vinci X and Xi Surgical Systems Recall (April 2, 2026).