Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300
This recall has been terminated (originally issued November 1, 2005).
- Company
- Boston Scientific
- Recall Initiated
- March 14, 2005
- Posted
- November 1, 2005
- Terminated
- December 13, 2005
- Recall Number
- Z-0112-06
- Quantity
- 69 units distributed worldwide
- 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
32 units have been distributed throughout the US, and 37 units distributed internationally.
Lot / Code Info
All lots
Root Cause
Other
Action Taken
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.