Carestation 620 & 650 (2019-11-25)
- Starting date:
- November 25, 2019
- Posting date:
- December 13, 2019
- 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-71873
Last updated: 2019-12-13
Affected Products
- Carestation 620
- Carestation 650
Reason
GE healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation without intervention could lead to hypoxia.
Affected products
-
Carestation 620
Lot or serial number
SM618370064MA
SM618450035MA
SM618460033MA
SM618460053MA
SM618460058MA
Model or catalog number
1012-9620-000
Companies
- Manufacturer
-
Datex-Ohmeda, Inc.
9900 Innovation Drive
Madison
53326
Wisconsin
UNITED STATES
B. Carestation 650
Lot or serial number
SM718040037MA
SM719110015MA
SM719110016MA
Model or catalog number
1012-9650-000
Companies
- Manufacturer
-
Datex-Ohmeda, Inc.
9900 Innovation Drive
Madison
53326
Wisconsin
UNITED STATES