FDA (Devices) recall action 68531
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.
In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue
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 20 units of the IS4000 da Vinci Xi 30 Degree, 8mm Endoscope because an orange-yellow tint in the surgical view can make it difficult to differentiate between tissue.
Intuitive Surgical is recalling 19 units of the IS4000 da Vinci Xi 0 Degree, 8mm Endoscope because an orange-yellow tint in the surgical view can make it difficult to differentiate between tissue.