FDA (Devices) recall action 84335
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Intuitive Surgical is recalling 52 da Vinci X surgical systems worldwide due to defective capacitors that may cause vision loss or system errors.
Intuitive Surgical is recalling 123 da Vinci Xi surgical systems worldwide due to potentially defective capacitors that may cause vision loss or system errors.
Intuitive Surgical is recalling four da Vinci SP Surgical Systems because defective capacitors on circuit boards may cause vision loss or non-recoverable system errors.