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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-63576
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 incomplete seal can exist between the disposable absorber and the breathing circuit lower assembly of the CareStation 600 series systems. This incomplete seal can allow rebreathing of patient gases that have bypassed the carbon dioxide (CO2) absorbent material and could result in unintended elevated inspired levels of co2 (FICO2), which could lead to hypercarbia.
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