Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

The Precision Implantable Pulse Generator, Model Number SC-1110

FDA Recall Z-0700-2007 · Posted 2007-03-31

Recalling FirmAdvanced Bionics Corp
Recall StatusTerminated
Product CodeLGW
Date Initiated2007-01-30
Date Terminated2012-01-25
Product Quantity5 unimplanted devices; 52 implanted devices

Reason for Recall

The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.

Firm Action

March 2007 by letter to physicians who had implanted the units notifying them of the recall and future upgrade by wireless RF telemetry.

Root Cause

Other

Distribution Pattern

Nationwide including Puerto Rico

Official Source

View FDA Recall →

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

↑