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Datex-Ohmeda Anesthesia Delivery System Main Units (2015-12-18)
- Starting date:
- December 18, 2015
- Posting date:
- January 25, 2016
- 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-56776
Affected Products
- S/5 AESPIRE 7900 SMARTVENT ANESTHESIA SYSTEM - Main Unit
- AVANCE CS2 - Main Unit
- AISYS CS2 ANESTHESIA MACHINE MAIN UNIT
Reason
The drive gas check valve could become stuck in a fixed open position which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
Affected products
A. S/5 AESPIRE 7900 SMARTVENT ANESTHESIA SYSTEM - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
1009-9012-000
Companies
- Manufacturer
-
Datex-Ohmeda
3030 Ohmeda Drive, P.O. Box 7550,
Madison
53707-7550
Wisconsin
UNITED STATES
B. AVANCE CS2 - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
1009-9050-000
Companies
- Manufacturer
-
Datex-Ohmeda
3030 Ohmeda Drive, P.O. Box 7550,
Madison
53707-7550
Wisconsin
UNITED STATES
C. 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