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Recall Observatory FDA recall evidence

Device 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

Z-2958-2018

July 26, 2018

Class II

Product summary

Firm
Covidien LLC
Event
Event 80804
Status
Ongoing
Classification
Class II
Quantity
BIS 46,961; Spare Batteries: 6,937
Official record key
device-enforcement:Z-2958-2018

Official wording

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

Code information: Batteries with date code 3114 or older (Week 31 of 2014)

Distribution pattern: Nationwide Foreign: Australia, New Zealand

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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