Recall
8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
Intuitive Surgical, Inc. · 24 March 2005
- Status
- Recall terminated
- Why, in the FDA's words
- “The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.”
- Recall began
- 24 March 2005
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
- Concerns
- K012833
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.