Recall Z-0088-2014— Intuitive Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2011-10-17, terminated 2013-10-28. It names one FDA 510(k) clearance: K081137. Product: da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.. Reason: Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-10-17
- Terminated
- 2013-10-28
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
Reason for recall
Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
Data sourced from openFDA. This site is unofficial and independent of the FDA.