Z-2958-2018 Class II Ongoing
FDA device recall Z-2958-2018 was initiated by Covidien LLC on Jul 26, 2018 and is designated Class II. Reason for recall: Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems The recall status is ongoing. Affected quantity: BIS 46,961; Spare Batteries: 6,937.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 5, 2018
- Initiation Date
- Jul 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- BIS 46,961; Spare Batteries: 6,937
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
Distribution Pattern
Nationwide Foreign: Australia, New Zealand
Code Information
Batteries with date code 3114 or older (Week 31 of 2014)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2958-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026