BIS Complete Monitoring System (2018-07-26)

Starting date:

July 26, 2018

Posting date:

August 17, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67386

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  Reason
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  Affected products

Affected products

BIS Complete Monitoring System

Reason

Replacement instructions were revised for the Li-Ion battery packs used in BIS Vista Monitoring System. These revised instructions will require battery pack replacement after 4 years due to the potential for aged battery packs to experience an internal short that may result in a thermal event.

Affected products