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The Precision Implantable Pulse Generator, Model Number… recallZ-0700-2007 · Advanced Bionics Corp · initiated Jan 30, 2007

Terminated All recalls posted in March 2007

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 Bionics Corp 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

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

FDA root cause category: Other

What the company is doing

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

Recall details

Recall number
Z-0700-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 30, 2007
Posted by the FDA
Mar 31, 2007
Recalling firm
Advanced Bionics Corp
Quantity
5 unimplanted devices; 52 implanted devices
Product code
LGW
FDA submissions
P030017
Distribution
Nationwide including Puerto Rico

Product description

The Precision Implantable Pulse Generator, Model Number SC-1110

Code information (models, lots, serial numbers)

161773, 161898, 161934, 161969, 160753,102331,103463,103497,103525,160041,160077, 160080,160088,160090,160091,160092,16009,160096, 160103,160104,160105,160107,160108,160110,160113, 160115,160141,160142,160144,160146,160602,161028, 161065,161222,161350,161415,161425,161430,161457, 161484,161497,161508,161579,161644,161658,161674, 161680,161681,161700,161751,161760,161790,161807, 161840,161853,810024,810051

Other devices under the same FDA submission

94 devices cleared under P030017 — 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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