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Carestation 620 & 650 (2017-11-03)
- Starting date:
- November 3, 2017
- Posting date:
- November 22, 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-65214
Affected products
A. CARESTATION 620
B. CARESTATION 650
Reason
The following issue is being addressed by GE Healthcare file no. FMI 34086: GE Healthcare has recently become aware that an incomplete seal can exist between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 series systems. An incomplete seal can allow rebreathing of patient gases that have bypassed the CO2 absorbent material and could result in unintended elevated levels of inspired CO2 (FICO2), which could lead to hypercarbia. There have been no injuries reported as a result of this issue.
Affected products
A. CARESTATION 620
Lot or serial number
More than 10 numbers, contact manufacturer.
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
More than 10 numbers, contact manufacturer.
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