Carescape R860 (2018-10-04)
- Starting date:
- October 4, 2018
- Posting date:
- October 26, 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-68094
Affected products
Carescape R860
Reason
The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway or from the ventilator outlet port. This disconnection could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia.
Affected products
Carescape R860
Lot or serial number
- 17/00951
- 17/01174
- 17/01937
- 17/01994
- 17/02372
- 17/02393
- 18/00126
- 18/00127
- 18/00128
- 18/00129
- 18/00130
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