Agency classClass IIOur severity:High FDA (Devices)·Z-2958-2018·Announced 2018-09-05

FDA Recalls Li-ion Battery Packs for BIS Monitoring Systems

The FDA is recalling Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems due to a Class II safety issue.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which the rubric maps to a 'High' severity score (3) as it represents a risk-of-harm product where the probability of serious adverse health consequences is remote.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. The recall involves 46,961 BIS units and 6,937 spare batteries manufactured by Covidien LLC. The affected products are identified by Product Number/CFN 186-0208 and UDI-Device Identifier 10884521130319.

The recall is limited to batteries with a date code of 3114 or older, which corresponds to Week 31 of 2014. These products were distributed nationwide in the United States as well as in Australia and New Zealand.

The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Users should check their inventory for the specific date codes and product identifiers listed in the recall notice.

The recalled product

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
Manufacturer: Covidien LLC
Category: Medical Device — Monitoring Systems
Hazard: battery-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Batteries with date code 3114 or older (Week 31 of 2014)

Distribution

Distributed nationwide across the United States.

Same manufacturer · Covidien LLC

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