—#166517

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

FDA product code: OLW — Index-Generating Electroencephalograph Software
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K072286
Affected lot / code info: Batteries with date code 3114 or older (Week 31 of 2014)

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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).

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: Nationwide Foreign: Australia, New Zealand

Timeline

Recall initiated: 2018-07-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166517. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.