Date Initiated by Firm |
April 18, 2008 |
Date Posted |
September 17, 2008 |
Recall Status1 |
Terminated 3 on March 25, 2011 |
Recall Number |
Z-1811-2008 |
Recall Event ID |
48085 |
510(K)Number |
K070947
|
Product Classification |
Endoscope and accessories - Product Code NAY
|
Product |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02; Product is manufactured and distributed by Intuitive Surgical, Inc. Sunnyvale, CA . The IS2000 CPG is used during cardiac ablation procedures. |
Code Information |
Lot Number: 802011 |
Recalling Firm/ Manufacturer |
Intuitive Surgical, Inc. 1266 Kifer Rd Sunnyvale CA 94086-5304
|
For Additional Information Contact |
408-523-2100
|
Manufacturer Reason for Recall |
The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks associated are loss of operability of the instrument, delay in surgery, and loss of dexterity.
|
FDA Determined Cause 2 |
Software design |
Action |
On April 18, 2008 an Urgent Device Recall letter was issued to customers. Consignees were notified via e-mail and were instructed to return the product. Customers were instructed to segregate the product in a secure area for Intuitive Surgical CSRs. If you have any questions contact Karen Uyesugi at (408) 523-2100. |
Quantity in Commerce |
11 |
Distribution |
Class II Recall - Nationwide Distribution --- including states of NC, OH, GA and WI. |
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.
|