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Carescape R860 (Evair component) (2015-07-30)
- Starting date:
- July 30, 2015
- Posting date:
- August 11, 2015
- 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-54598
Affected Products
A. Carescape R860 (Evair component)
Reason
The following issue is being addressed by GE healthcare file no. FMI 34066: the EVair component manufacturer, Imtmedical AG, is conducting a field corrective action. Imtmedical has identified that potential friction of cables and tubing internal to the EVair compressor may result in an inability for the compressor to output compressed air. There is a potential for temporary oversupply of oxygen to the patient as a result of this failure because the GE Healthcare ventilators are designed to ventilate with 100% oxygen in the case of loss of input air supply pressure.
Affected products
A. Carescape R860 (Evair component)
Lot or serial number
>10, contact mfg.
Model or catalog number
1506-8600-000
Companies
- Manufacturer
-
Datex-Ohmeda
Inc.
3030 Ohmeda Drive
Wisconsin
UNITED STATES