Cardiosave System - Battery Only (2021-09-23)

Starting date:

September 23, 2021

Posting date:

October 1, 2021

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-76565

Last updated:
2021-10-01

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  Reason
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  Affected products

Affected Products

Cardiosave System - Battery Only

Reason

A cardiosave Lithium-ION battery pack (0146-00-0097) used during protocol testing failed to meet the minimum runtime requirement per getinge's internal product specification. These nonconforming batteries were inadvertently released to customers.

Affected products