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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 BIS see related information
Date Initiated by Firm July 26, 2018
Create Date August 30, 2018
Recall Status1 Open3, Classified
Recall Number Z-2958-2018
Recall Event ID 80804
510(K)Number K072286  
Product Classification Index-generating electroencephalograph software - Product Code OLW
Product Li-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)          
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact same
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
Action Medtronic 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 Commerce BIS 46,961; Spare Batteries: 6,937
Distribution Nationwide Foreign: Australia, New Zealand
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OLW and Original Applicant = ASPECT MEDICAL SYSTEMS, INC.
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