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GE Datex-OHMEDA Avance Anesthesia System and AVANCE CS2-Main Unit (2016-10-25)
- Starting date:
- October 25, 2016
- Posting date:
- November 15, 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-61026
Affected Products
- GE Datex-OHMEDA Avance Anesthesia System
- AVANCE CS2-Main Unit
Reason
GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance, and Amingo Anesthesia Devices can transition to a system malfunction state if the lower storage drawer containing the optimal large tray insert accessory is closed with an abnormally high amount of force.
Affected products
A. GE Datex-OHMEDA Avance Anesthesia System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1009-9002-000
Companies
- Manufacturer
-
Datex-Ohmeda, Inc.
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, Inc.
3030 Ohmeda Drive, P.O. Box 7550,
Madison
53707-7550
Wisconsin
UNITED STATES