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Terminated

Software version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting implantable pulse generators of the Eon, Genesis, and Renew family.

FDA Recall Z-3091-2011 · Posted 2011-08-30

Recalling FirmAdvanced Neuromodulation Systems
Recall StatusTerminated
Product CodeLGW
Date Initiated2009-06-02
Date Terminated2012-09-27
Product Quantity14 units

Reason for Recall

Product programmed with unapproved software was distributed.

Firm Action

St. Jude Medical Neuromodulation contacted all affected customers by telephone between June 2, 2009 and June 5, 2009. Customers were given information about the product, problem and action to be taken. All affected devices were returned to the firm as instructed.

Root Cause

Software change control

Distribution Pattern

Distributed in New Hampshire and Puerto Rico.

Official Source

View FDA Recall →

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

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