The Recall Desk
HighFDA (Devices)·Z-3254-2018·Announced 2018-10-03

Intuitive Surgical Recalls da Vinci Redundant Medical Grade Power Supply Units

Intuitive Surgical is recalling specific da Vinci Surgical System power supply units that were manufactured incorrectly and may fail during use.

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 used during surgery where a power failure could pose a risk of harm, but the source text does not report any injuries, illnesses, or deaths, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Intuitive Surgical, Inc. is recalling certain Redundant Medical Grade Power Supply (RMGPS) units used in the da Vinci Si, X, and Xi Surgical Systems. The recall involves 1,014 units currently installed on systems. These specific units, located in the Surgeon Console and Patient Side Carts, were manufactured incorrectly.

The defect may cause the power supply units to fail prior to or during use. The da Vinci System is used to perform minimally invasive surgery and requires all three components (Surgeon Console, Patient Cart, and Vision Cart) to be powered on to be functional. A failure of the RMGPS could impact the system's operation.

The affected units were distributed worldwide, including in the United States and numerous other countries. Intuitive Surgical is the recalling firm. No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the defect and the recall action.

The recalled product

Product
da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasiv
Affected units
1,014

Distribution

Distributed nationwide across the United States.