PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: September 5, 2018 Initiated: July 26, 2018 #Z-2958-2018

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Covidien LLC
Units Affected
BIS 46,961; Spare Batteries: 6,937
Distribution
Nationwide Foreign: Australia, New Zealand
Location
North Haven, CT

Frequently Asked Questions

What product was recalled?
Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319. Recalled by Covidien LLC. Units affected: BIS 46,961; Spare Batteries: 6,937.
Why was this product recalled?
Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
Which agency issued this recall?
This recall was issued by the FDA Devices on September 5, 2018. Severity: Moderate. Recall number: Z-2958-2018.