medical Class II Updated 2020-02-12

Intuitive Surgical, Inc. recalls da Vinci SP Surgical System, SP1098, 00886874114605 Product

Recalled Product

da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.


Hazard / Issue

The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: System Serial # PSC Serial # VSC Serial # SP0047 Not Affected 675054 SP0049 Not Affected 674261 SP0050 Not Affected 675051 SP0054 Not Affected 682482
View official government recall

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