This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Carestation 620 and 650 (2017-05-02)
- Starting date:
- May 2, 2017
- Posting date:
- June 12, 2017
- 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-63582
Affected Products
A. Carestation 620
B. Carestation 650
Reason
GE Healthcare has recently become aware of a potential safety issue with the CareStation 620, 650 and 650C. An unexpected transition to a system malfunction state can occur on the CareStation 600 series systems. When this does occur, you will see this message displayed on the screen: "System malfunction internal problem prevents normal operation. Use backup ventilation. To restart, turn power off and on." if the system malfunction is left unresolved, it could result in loss of mechanical patient ventilation, which could lead to hypoxia.
Affected products
A. Carestation 620
Lot or serial number
- SM616200018MA
- SM616310012MA
- SM616310029MA
- SM616430025MA
- SM616430026MA
- SM617100018MA
- SM617100026MA
- SM617100027MA
- SM617100155MA
Model or catalog number
1012-9620-000
Companies
- Manufacturer
-
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, P.O. Box 7550,
Madison
53707-7550
Wisconsin
UNITED STATES
B. Carestation 650
Lot or serial number
SM716200045MA
SM716430070MA
SM717020049MA
SM717080056MA
SM717080057MA
SM717080058MA
SM717080059MA
SM717100033MA
SM717100036MA
Model or catalog number
1012-9650-000
Companies
- Manufacturer
-
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, P.O. Box 7550,
Madison
53707-7550
Wisconsin
UNITED STATES