This page has been archived on the Web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.
AISYS CS2 ANESTHESIA MACHINE MAIN UNIT (2016-02-18)
- Starting date:
- February 18, 2016
- Posting date:
- March 4, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-57396
Affected Products
A. AISYS CS2 ANESTHESIA MACHINE MAIN UNIT
Reason
GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices. Delivery of this momentary bolus of anesthetic agent is potentially hazardous because it could lead to hypotension in certain vulnerable pediatric patients when 21% oxygen (air only) is used. There have been no injuries reported as a result of this issue.
Affected products
A. AISYS CS2 ANESTHESIA MACHINE MAIN UNIT
Lot or serial number
All Lots
Model or catalog number
1011-9050-000
Companies
- Manufacturer
-
Datex-Ohmeda
3030 Ohmeda Drive, P.O. Box 7550,
Madison
53707-7550
Wisconsin
UNITED STATES