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Terminated

Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications.

FDA Recall Z-0841-04 · Posted 2004-07-20

Recalling FirmGyrus Medical, Inc
Recall StatusTerminated
Product CodeGEI
Date Initiated2003-12-05
Date Terminated2006-12-28
Product Quantity14

Reason for Recall

The generator may malfunction when used in close proximity to a monopolar generator.

Firm Action

On December 05, 2003, the firm sent recall notices to their affected customers by Certified Mail. The customers were notified that the firm would call them to arrange for pick up and correction of the device.

Root Cause

Other

Distribution Pattern

Nationwide throughout the United States.

Official Source

View FDA Recall →

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

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