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Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4 recallZ-1409-2010 · Boston Scientific Neuromodulation Corporation · initiated Mar 19, 2010

Terminated All recalls posted in April 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Neuromodulation Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-1409-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 19, 2010
Posted by the FDA
Apr 16, 2010
Recalling firm
Boston Scientific Neuromodulation Corporation
Quantity
62 units
Product code
LGW
FDA submissions
P030017
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

Product description

Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

94 devices cleared under P030017 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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