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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 February 18, 2005
Date Posted October 19, 2005
Recall Status1 Terminated 3 on January 30, 2006
Recall Number Z-0064-06
Recall Event ID 33488
Product Classification Catheter, Electrode Recording, Or Probe, Electrode Recording - Product Code DRF
Product Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System,
Catalog/Model Numbers: 8200010, 8200TWA0
Code Information All lots 
Recalling Firm/
Manufacturer
Boston Scientific
2710 Orchard Pkwy
San Jose CA 95134-2012
For Additional Information Contact Pierre A. Boisier
408-895-3500
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 2/18/05 and 5/18/05 via FedEx. On the letter, a service reply form is included to monitor responses and schedule appointments to replace the PAM unit component.
Distribution Product was released for distribution to 38 consignees in US nationwide. International distribution includes EU and Canada. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers.
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.
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