High FDA (Devices)·Z-2260-2020·Announced 2020-06-10

Intuitive Recalls 17 da Vinci SP Surgical Systems Due to Software Anomaly

Intuitive Surgical is recalling 17 da Vinci SP surgical systems because a software anomaly may cause mechanical vibration of instrument tips and the endoscope under rare conditions.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential for mechanical vibration during surgery, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Intuitive Surgical, Inc. is recalling 17 units of the da Vinci SP surgical system. The recall is due to a software anomaly that may trigger mechanical vibration of the instrument tips and the endoscope. This issue has the potential to occur only under extremely rare specific conditions: 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.

The affected units are distributed in the United States in Ohio, Pennsylvania, New York, Minnesota, Tennessee, Texas, Oregon, Illinois, Maryland, New Jersey, and Alabama, as well as in South Korea. The specific serial numbers for the recalled units are SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, and SP0030.

The source text does not specify the corrective action or instructions for consumers or healthcare providers. Users should contact Intuitive Surgical for further information regarding the recall and any necessary remediation.

The recalled product

Product: da Vinci SP surgical system
Manufacturer: Intuitive Surgical, Inc.
Category: Medical Device — Surgical Robot
Hazard: mechanical-vibration
Affected units: 17

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

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

Distribution

Distributed in 10 states:

Same manufacturer · Intuitive Surgical, Inc.

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Same hazard · mechanical vibration