Carescape R860 (2017-12-13)
- Starting date:
- December 13, 2017
- Posting date:
- February 9, 2018
- 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-65908
Affected products
Carescape R860
Reason
Potential for the display processor to experience an unexpected failure where device screen will temporarily go blank and display error code "ec01 xx". This results in loss of monitored data being displayed to user. No injuries have been reported.
Affected products
Carescape R860
Lot or serial number
All lots.
Model or catalog number
1506-8600-000
Companies
- Manufacturer
-
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, P.O. Box 7550
Madison
53707-7550
Wisconsin
UNITED STATES