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U.S. Department of Health and Human Services

Class 2 Device Recall iLab

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  Class 2 Device Recall iLab see related information
Date Initiated by Firm March 06, 2006
Date Posted April 22, 2006
Recall Status1 Terminated 3 on November 28, 2007
Recall Number Z-0789-06
Recall Event ID 34951
510(K)Number K051679  
Product Classification Utrasound Imaging System - Product Code DQO
Product iLab Utrasound Imaging System, software controlled Imaging Catheter.
Code Information Model Numbers M0004EPiL120CART0, serial number 4037; H749iLab120CART0, serial numbers 4041, 4020, 4056, 4018, 4037; H749iLab120CARTD0, serial number 4064; H749iLab120CARTR0, serial number 4022; H749iLab120INS0, serial numbers 4016, 4015, 4008, 4043.
Recalling Firm/
Manufacturer		 Boston Scientific Target
4701 Lakeview Blvd
Fremont CA 94537
For Additional Information Contact Tara Lopez
510-440-7874
Manufacturer Reason
for Recall		 Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters only)
FDA Determined
Cause 2		 Other
Action The firm initiated recall actions on March 6, 2006. On March 21, 2006, the firm issued notification letters to all appropriate personnel at hospitals and user facilities to inform them of actions taken by Boston Scientific to remediate any risks.
Quantity in Commerce 23 units (13 in the US, 10 outside)
Distribution Product was distributed to 13 US consignees and 10 foreign consignees.
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 = DQO and Original Applicant = BOSTON SCIENTIFIC CORP.
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