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