FDA Device

Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300

Hazard

The device has the potential for overheating its transformer and has the potential for fire hazard.

What You Should Do

Remedy

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.

Products

Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300
Brand
Boston Scientific
UPC
All lots

Units Affected

69 units distributed worldwide