Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0
This recall has been terminated (originally issued October 19, 2005).
- Company
- Boston Scientific
- Recall Initiated
- February 18, 2005
- Posted
- October 19, 2005
- Terminated
- January 30, 2006
- Recall Number
- Z-0064-06
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The device has the potential for overheating its transformer and has the potential for fire hazard.
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.
Lot / Code Info
All lots
Root Cause
Other
Action Taken
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.