Health product recall

Carestation 650 (2018-07-24)

Starting date:
July 24, 2018
Posting date:
August 17, 2018
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-67384

Affected products

Carestation 650

Reason

On systems equipped with the Auxiliary Common GGAS Utlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia. It would still be possible to ventilate the patient using the circle breathing system in the manual bag or mechanical ventilation modes.

Affected products

Carestation 650

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

1012-9650-000

Companies
Manufacturer

Datex-Ohmeda, Inc.

3030 Ohmeda Drive, P.O. Box 7550

Madison

53707-7550

Wisconsin

UNITED STATES