Date Initiated by Firm | March 15, 2013 |
Date Posted | April 13, 2013 |
Recall Status1 |
Terminated 3 on September 04, 2014 |
Recall Number | Z-1110-2013 |
Recall Event ID |
64755 |
510(K)Number | K081137 |
Product Classification |
System,surgical,computer controlled instrument - Product Code NAY
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Product | IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000.
Arm drapes protect equipment from contamination. |
Code Information |
Model number 550650-05 (P8) |
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 408-523-2100 |
Manufacturer Reason for Recall | Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Intuitive Surgical sent an "Urgent Medical Device Correction" letter dated April 1, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 800-876-1310 for questions regarding this letter. |
Quantity in Commerce | 1642 customers |
Distribution | Worldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom. |
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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