The Precision Implantable Pulse Generator, Model Number SC-1110
FDA device recall Z-0700-2007 · posted 2007-03-31 · Terminated
Recall details
- Recalling firm
- Advanced Bionics Corp
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LGW
- Quantity affected
- 5 unimplanted devices; 52 implanted devices
- Distribution
- Nationwide including Puerto Rico
- Date initiated
- 2007-01-30
- Date posted
- 2007-03-31
- Date terminated
- 2012-01-25
- Location
- Sylmar, CA
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