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Terminated

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

FDA Recall Z-0064-06 · Posted 2005-10-19

Recalling FirmBoston Scientific
Recall StatusTerminated
Product CodeDRF
Date Initiated2005-02-18
Date Terminated2006-01-30

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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