Z-2958-2018Class II

Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208...

Name: Z-2958-2018 Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208...
Creator: Covidien LLC
Published: 2018-07-26
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-07-26 / Open, Classified / root cause: design

FDA source

Covidien LLC began a recall of Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319 on 2018-07-26. FDA classified it as Class II and gives the reason as "Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2958-2018
Classification: Class II
Status: Open, Classified
Initiated: 2018-07-26
Posted: 2018-08-30
Recalling firm: Medtronic, Inc.
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
Product code: OLW Index-Generating Electroencephalograph Software
Reason for recall: Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
Root cause tag: design
FDA root cause: Device Design
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).
Quantity in commerce: BIS 46,961; Spare Batteries: 6,937
Distribution: Nationwide Foreign: Australia, New Zealand
Product codes and lots: Batteries with date code 3114 or older (Week 31 of 2014)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2958-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2958-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-09-05	2018-08-30

Product code OLW

K072286Class IIBis EEG Vista Monitor System and BisxAspect Medical Systems, Inc. / cleared 2007-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)