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

• 
  Reason
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  Affected products

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