U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The device has the potential for overheating its transformer and has the potential for fire hazard.
조치
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.
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.
제품 설명
Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, || Catalog/Model Numbers: 8200010, 8200TWA0