| Class 2 Device Recall da Vinci Instrument Control Box | |
Date Initiated by Firm | June 08, 2013 |
Date Posted | July 11, 2013 |
Recall Status1 |
Terminated 3 on January 22, 2014 |
Recall Number | Z-1689-2013 |
Recall Event ID |
65590 |
510(K)Number | K110639 |
Product Classification |
System,surgical,computer controlled instrument - Product Code NAY
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Product | da Vinci Instrument Control Box, model number ICB3000;
Manufactured by Intuitive Surgical, Sunnyvale, CA 94086.
Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use. |
Code Information |
Part number 372012-96: Serial numbers: 323986 324198. |
Recalling Firm/ Manufacturer |
Intuitive Surgical, Inc. 1266 Kifer Rd Bldg 100 Sunnyvale CA 94086-5304
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For Additional Information Contact | Richard Reeves 408-523-2244 |
Manufacturer Reason for Recall | Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. |
FDA Determined Cause 2 | Software design |
Action | Intuitive Surgical sent an Urgent Device Correction notice dated July 15, 2013, to all affected customers by Federal Express.The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all affected personnel were fully informed of the notification and that the notification should be forwarded to other managers within their facility. Customers were also instructed to complete and return the attached Acknowledgment Form to acknowledge receipt of the notification. Customers with questions were instructed to call Customer Service at 800-876-1310, Option 3.
For questions regarding this recall call 408-523-2244. |
Quantity in Commerce | 30 total, all devices |
Distribution | Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = NAY
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