RecallDepth

Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4

Company
Boston Scientific Neuromodulation Corporation
Recall Initiated
March 19, 2010
Posted
April 16, 2010
Terminated
February 29, 2012
Recall Number
Z-1409-2010
Quantity
62 units
Firm Location
Valencia, CA

Reason for Recall

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.

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 / Code Info

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

Root Cause

Other

Action Taken

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.

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