FDA Device

The Precision Implantable Pulse Generator, Model Number SC-1110

Hazard

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

What You Should Do

Remedy

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

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Products

The Precision Implantable Pulse Generator, Model Number SC-1110
Brand
Advanced Bionics Corp
UPC
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

Units Affected

5 unimplanted devices; 52 implanted devices

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