Aisys Carestation and Aisys CS2 (2018-09-27)
- Starting date:
- September 27, 2018
- Posting date:
- June 7, 2019
- 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-70111
Last updated: 2019-06-07
Affected Products
- Aisys Carestation
- Aisys CS2
Reason
Upgraded Aisys Anesthesia devices (i.e. Aisys devices upgraded to software version 11) and Aisys CS2 anesthesia devices with end tidal control option may have the inability to set fresh gas settings and/or PSVPro option may have non-functional back-up ventilation occur after cycling procedure.
Affected products
A. Aisys Carestation
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1011-9000-000
Companies
- Manufacturer
-
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, P.O. Box 7550
Madison
53707-7550
Wisconsin
UNITED STATES
B. Aisys CS2
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1011-9050-000
Companies
- Manufacturer
-
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, P.O. Box 7550
Madison
53707-7550
Wisconsin
UNITED STATES