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.
|