Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems — Class II medical device recall Z-2958-2018
Ongoing recall by Covidien LLC, reported 2018-09-05, distributed nationwide. Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring System
| Recall number | Z-2958-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2018-07-26 |
| Classified | 2018-08-30 |
| Reported by FDA | 2018-09-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, NZ |
| UPC / GTIN / UDI-DI | 10884521130319 |
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
Reason for recall
Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2958-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.