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Software version 3.3 for Rapid Programmer devices, Model… recallZ-3091-2011 · Advanced Neuromodulation Systems · initiated Jun 2, 2009

Terminated All recalls posted in August 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Advanced Neuromodulation Systems or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Product programmed with unapproved software was distributed.

FDA root cause category: Software change control

What the company is doing

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.

Recall details

Recall number
Z-3091-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 2, 2009
Posted by the FDA
Aug 30, 2011
Recalling firm
Advanced Neuromodulation Systems
Quantity
14 units
Product code
LGW
FDA submissions
P010032
Distribution
Distributed in New Hampshire and Puerto Rico.

Product description

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.

Code information (models, lots, serial numbers)

Serial numbers: 101565, 101544, 101555, 101548, 101561, 101551, 101563, 101546, 101556, 101553, 101554, 101558, 101545, and 101566

Other devices under the same FDA submission

110 devices cleared under P010032 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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