FDA-Device2018-09-05Class II

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

Covidien LLC
Hazard

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

Sold states
Nationwide Foreign: Australia, New Zealand
Affected count
BIS 46,961; Spare Batteries: 6,937
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2958-2018

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