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Terminated

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

FDA Recall Z-0112-06 · Posted 2005-11-01

Recalling FirmBoston Scientific
Recall StatusTerminated
Product CodeDQK
Date Initiated2005-03-14
Date Terminated2005-12-13
Product Quantity69 units distributed worldwide

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 April 1, 2005. On the letter, a service reply form is included to monitor responses and schedule appointments to replace the SAM unit.

Root Cause

Other

Distribution Pattern

32 units have been distributed throughout the US, and 37 units distributed internationally.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992912CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATHCardiac Pathways Corp. · 2000-03-08

Official Source

View FDA Recall →

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

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