Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319
- Company
- Covidien Llc
- Recall Initiated
- July 26, 2018
- Recall Number
- Z-2958-2018
- Quantity
- BIS 46,961; Spare Batteries: 6,937
- Firm Location
- North Haven, CT
Reason for Recall
Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
Distribution
Nationwide Foreign: Australia, New Zealand
Lot / Code Info
Batteries with date code 3114 or older (Week 31 of 2014)
Root Cause
Device Design
Action Taken
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).