Recall Z-2958-2018 ยท OLW Index-Generating Electroencephalograph Software
Covidien LLC
Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319
| Date | Jul 26, 2018 |
| Status | Open, Classified |
| Reason | Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems |
| 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 connect |
| Quantity | BIS 46,961; Spare Batteries: 6,937 |
| Distribution | Nationwide Foreign: Australia, New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX Aspect Medical Systems, Inc., Nov 20, 2007 |