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AISYS CS2 ANESTHESIA MACHINE MAIN UNIT (2016-03-10)
- Starting date:
- March 10, 2016
- Posting date:
- April 4, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-57770
Affected Products
AISYS CS2 ANESTHESIA MACHINE MAIN UNIT
Reason
The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 LPM required by ISO 10079-3. If this issue is left unresolved, it could result in inadequate suction performance to clear the airway and inadequate ventilation of the patient. There have been no injuries reported as a result of this issue.
Affected products
AISYS CS2 ANESTHESIA MACHINE MAIN UNIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1011-9050-000
Companies
- Manufacturer
-
Datex-Ohmeda
3030 Ohmeda Drive, P.O. Box 7550,
Madison
53707-7550
Wisconsin
UNITED STATES