Health product recall

CARESCAPE ONE (2020-06-24)

Starting date:
June 24, 2020
Posting date:
July 10, 2020
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-73515

Last updated:
2020-07-10

Affected Products

CARESCAPE ONE

Reason

If a patient presents with a V Fib arrhythmia when a CARESCAPE ONE (CSONE) is docked to a host monitor that is in the Learning process from CSONE, the monitor may not alarm for a V Fib arrhythmia. In rare circumstances, this issue could result in delayed clinical assessment.

Affected products

CARESCAPE ONE

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2078006-001

Companies
Manufacturer

GE Medical Systems Information Technologies, Inc.

8200 W Tower Ave

Milwaukee

53223

Wisconsin

UNITED STATES