This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
GE Datex-Ohmeda Anestheisa Systems (2013-08-28)
- Starting date:
- August 28, 2013
- Posting date:
- April 30, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-39211
Recalled products
- Aisys Carestation Anesthesia System
- Engstrom Carestation
- GE Datex -Ohmeda Avance Anesthesia System
- Aespire View - Anethesia Machine
- Aisys Carestation Anesthesia System - Field Upgrade Kit
- GE Datex -Ohmeda Avance Anesthesia System - Software version 8.x
- Avance C2
Reason
As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions.
Affected products
A. Aisys Carestation Anesthesia System
Lot or serial number
Not applicable
Model or catalog number
- 1011-9000-000
Companies
- Manufacturer
-
Datex-Ohmeda
3030 Ohmeda Drive, P.O. Box 7550,
Madison
53707-7550
Wisconsin
UNITED STATES
B. Engstrom Carestation
Lot or serial number
Not applicable
Model or catalog number
- 1505-9000-000
Companies
- Manufacturer
-
Datex-Ohmeda
3030 Ohmeda Drive, P.O. Box 7550,
Madison
53707-7550
Wisconsin
UNITED STATES
C. GE Datex -Ohmeda Avance Anesthesia System
Lot or serial number
Not applicable
Model or catalog number
- 1009-9002-000
Companies
- Manufacturer
-
Datex-Ohmeda
3030 Ohmeda Drive, P.O. Box 7550,
Madison
53707-7550
Wisconsin
UNITED STATES
D. Aespire View - Anethesia Machine
Lot or serial number
Not applicable
Model or catalog number
- 1009-9212-000
Companies
- Manufacturer
-
Datex-Ohmeda
3030 Ohmeda Drive, P.O. Box 7550,
Madison
53707-7550
Wisconsin
UNITED STATES
E. Aisys Carestation Anesthesia System - Field Upgrade Kit
Lot or serial number
Not applicable
Model or catalog number
- M1210396
- M1210400
Companies
- Manufacturer
-
Datex-Ohmeda
3030 Ohmeda Drive, P.O. Box 7550,
Madison
53707-7550
Wisconsin
UNITED STATES
F. GE Datex -Ohmeda Avance Anesthesia System - Software version 8.x
Lot or serial number
Not applicable
Model or catalog number
- M1210416
Companies
- Manufacturer
-
Datex-Ohmeda
3030 Ohmeda Drive, P.O. Box 7550,
Madison
53707-7550
Wisconsin
UNITED STATES
G. Avance C2
Lot or serial number
Not applicable
Model or catalog number
- 1009-9050-000
Companies
- Manufacturer
-
Datex-Ohmeda
3030 Ohmeda Drive, P.O. Box 7550,
Madison
53707-7550
Wisconsin
UNITED STATES