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Terminated

Belos DR Implantable Cardioverter Defibrillator

FDA Recall Z-0072-04 · Posted 2003-10-31

Recalling FirmBiotronik Inc
Recall StatusTerminated
Product CodeLWS
Date Initiated2003-09-24
Date Terminated2005-02-28
Product Quantity1 device

Reason for Recall

Potential extended charge time anomalies.

Firm Action

Firm issued a letter dated September 24, 2003 recommending physicians schedule an immediate follow-up with affected patients.

Root Cause

Other

Distribution Pattern

The firm distributes to physicians located throughout the US.

Official Source

View FDA Recall →

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

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