FDA (Devices) recall action 64755
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
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 IS2000 user manuals for the da Vinci S system to provide revised instructions on sterile adapter engagement and instrument installation.
Intuitive Surgical is recalling IS3000 user manuals for da Vinci Si and Si-e systems to provide revised instructions for sterile adapter engagement and instrument installation.