FDA Medical Device Recalls (openFDA)
Boston Scientific Neuromodulation Corporation: Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4
- Recall number
- Z-1409-2010
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Product
- Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4
- Status
- Terminated
- Initiated
- 2010-03-19
- Posted
- 2010-04-16
- Terminated
- 2012-02-29
- Reason
- Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers. Based on Toshiba's investigation with Sony Corporation, they concluded that the battery cells in specific manufacturing lots could be affected.
- Root cause
- Other
- Action
- In a letter dated March 19, 2010 Boston Scientific informed consignees that it determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers, and telling them that they may be in possession of an affected product. They were advised that a Boston Scientific representative will contact them to arrange for an inspection of the Clinician Programmer (SC-7150-4). Until they have determined if the battery pack is affected, consignees were told they can only use their Toshiba portable computer with the original AC adapter power cord supplied with that computer, and were asked to remove the battery pack until its status is determined. Included with the letter was a Reply Verification Tracking Form which consignees were asked to complete the form following the instructions on the form and return to Boston Scientific in the enclosed postage paid return envelope or fax it to (877) 856-3546 by March 31, 2010. If they experience any issues they were told to cease using the Clinician Programmer and contact Boston Scientific's 24-hour Patient Care Hotline at (866) 360-4747. Customers can also contact the Field Action team by phone at (866) 684-7504 or by fax at (877) 856-3546 if they had any questions.
- Quantity
- 62 units
- Distribution
- Domestically to AR, CA, CO, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NY, OH, OR, PA, PR, SC, TX, VA, WI Internationally: Italy
- Lot, serial or model codes
- SERIAL #'s: 27059297H, 46080743H, 46080918H, 56066331H, 56069528H, 56069671H, 56069673H, 56069686H, 56072440H, 56072655H, 56072666H, 56072674H, 57014750H, 57014755H, 57014757H, 66084643H, 77048447H, 87040459H, 87040630H, 87040942H, 87040947H, 87040951H, 87040957H, 87042729H, 87042732H, 87043106H, 87043119H, 87058615H 87058616H, 87058618H, 87058849H, 87059667H, 87082650H, 87082900H, 87086049H, 87094579H, 87094580H, 87094590H, 87094593H, 87094596H, 87094597H, 87094738H, 96026241Hu, 96026251Hu, 97045074H, 97047825H, 97072474H, 97076337H, 97076339H, 97076666H, 97076671H, 97076770H, 97079617H, 97081025H, 97081842H, X6090220H, X6098238H, X6099082H, X7021190H, X7087236H, Z7014824H, Z7060102H
- 510(k) numbers
- not on file
- PMA numbers
- ["P030017"]
- Product code
- LGW
- Firm FEI
- 3006630150
- Firm city
- Valencia
- 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