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U.S. Department of Health and Human Services

Class 2 Device Recall Patient Side Cart Battery Box

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  Class 2 Device Recall Patient Side Cart Battery Box see related information
Date Initiated by Firm April 27, 2012
Date Posted July 04, 2014
Recall Status1 Terminated 3 on July 07, 2014
Recall Number Z-1994-2014
Recall Event ID 68593
510(K)Number K050369  K081137  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system.

Intuitive Surgical Inc.
Sunnyvale, CA 94086
Code Information Material number 371268-02 - al lots.
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Mark Johnson
408-523-2100
Manufacturer Reason
for Recall		 Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.
FDA Determined
Cause 2		 Device Design
Action No notification was sent. Issue is being addressed during routine maintenance or through complaint process.
Quantity in Commerce 2606
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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