FDA Device

Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0

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 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.

Products

Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0
Brand
Boston Scientific
UPC
All lots