FDA Medical Device Recalls (openFDA)
Advanced Bionics Corp: The Precision Implantable Pulse Generator, Model Number SC-1110
- Recall number
- Z-0700-2007
- Recalling firm
- Advanced Bionics Corp
- Product
- The Precision Implantable Pulse Generator, Model Number SC-1110
- Status
- Terminated
- Initiated
- 2007-01-30
- Posted
- 2007-03-31
- Terminated
- 2012-01-25
- Reason
- The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.
- Root cause
- Other
- Action
- March 2007 by letter to physicians who had implanted the units notifying them of the recall and future upgrade by wireless RF telemetry.
- Quantity
- 5 unimplanted devices; 52 implanted devices
- Distribution
- Nationwide including Puerto Rico
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P030017"]
- Product code
- LGW
- Firm FEI
- 1000220815
- Firm city
- Sylmar
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28