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Open, Classified

Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319

FDA Recall Z-2958-2018 · Posted None

Recalling FirmCovidien LLC
Recall StatusOpen, Classified
Product CodeOLW
Date Initiated2018-07-26
Product QuantityBIS 46,961; Spare Batteries: 6,937

Reason for Recall

Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems

Firm 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).

Root Cause

Device Design

Distribution Pattern

Nationwide Foreign: Australia, New Zealand

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072286BIS EEG VISTA MONITOR SYSTEM AND BISXAspect Medical Systems, Inc. · 2007-11-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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