Recall
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Intuitive Surgical, Inc. · 25 Oct 2018
- Status
- Recall terminated
- Why, in the FDA's words
- “The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.”
- Recall began
- 25 Oct 2018
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
- Concerns
- K173906
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.