Health product recall

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

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

Cardiosave System - Battery Only

Lot or serial number

181725430IP

Model or catalog number

0998-00-0800-XX

Companies
Manufacturer

Datascope Corp.

1300 Macarthur Blvd.

Mahwah

07430

New Jersey

UNITED STATES