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U.S. Department of Health and Human Services

Class 2 Device Recall BIS

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 Class 2 Device Recall BISsee related information
Date Initiated by FirmJuly 26, 2018
Create DateAugust 30, 2018
Recall Status1 Open3, Classified
Recall NumberZ-2958-2018
Recall Event ID 80804
510(K)NumberK072286 
Product Classification Index-generating electroencephalograph software - Product Code OLW
ProductLi-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319
Code Information Batteries with date code 3114 or older (Week 31 of 2014)          
FEI Number 1219930
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contactsame
203-492-5000
Manufacturer Reason
for Recall		Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
FDA Determined
Cause 2		Device Design
ActionMedtronic U.S. consignees were notified via Federal Express or certified mail on July 26, 2018, and the letter informs customers to inspect their batteries. Batteries with date code 3114 or older (Week 31 of 2014) exceed 4 years of age and should be removed from the monitor and disposed of according to facilitys standard process. Included with this notification are stickers to be placed on BIS" monitors when the battery pack is removed the stickers No Battery Installed should be placed on the monitors. The BIS Vista and View monitoring systems may be used without a battery pack only if connected to AC power source with emergency power backup system (Red Outlet).
Quantity in CommerceBIS 46,961; Spare Batteries: 6,937
DistributionNationwide Foreign: Australia, New Zealand
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OLW
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