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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific

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  Class 2 Device Recall Boston Scientific see related information
Date Initiated by Firm March 14, 2005
Date Posted November 01, 2005
Recall Status1 Terminated 3 on December 13, 2005
Recall Number Z-0112-06
Recall Event ID 33446
510(K)Number K992912  
Product Classification Computer, Diagnostic, Programmable - Product Code DQK
Product Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300
Code Information All lots
Recalling Firm/
Manufacturer
Boston Scientific
2710 Orchard Pkwy
San Jose CA 95134-2012
For Additional Information Contact Pierre A. Boisier
408-895-3670
Manufacturer Reason
for Recall
The device has the potential for overheating its transformer and has the potential for fire hazard.
FDA Determined
Cause 2
Other
Action The firm sent notification letters to its consignees on April 1, 2005. On the letter, a service reply form is included to monitor responses and schedule appointments to replace the SAM unit.
Quantity in Commerce 69 units distributed worldwide
Distribution 32 units have been distributed throughout the US, and 37 units distributed internationally.
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 = DQK and Original Applicant = CARDIAC PATHWAYS CORP.
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