da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems. Intuitive Surgical, Inc. Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Recall Z-1202-2012 · Posted 2012-03-13
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Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2012-02-06
Date Terminated2012-05-09
Product Quantity1966 systems are in commerce at hospital locations.
Reason for Recall
The holding brake, a component of the da Vinci S Surgical System, may allow passive uncontrolled motion due to gravity during specific power-off conditions.
Firm Action
Intuitive Surgical sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated February 3, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provided new instructions for use. Additionally, a Device Correction Response Form was enclosed for customers to complete and return via fax to 408-523-1390. Contact Intuitive Surgical Customer Service at 1-800-876-1310 for questions regarding this notice.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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