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R100 Ventilator System (2013-11-15)
- Starting date:
- November 15, 2013
- Posting date:
- February 3, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37527
Recalled Products
R100 Ventilator System
Reason
One report received of the actuation of ventilator alarm and buzzing sound after 16 hrs of patient oscillation in a hospital in Germany. The reason was a failure in the bonding of the diaphragm chamber producing leakage.
Affected products
R100 Ventilator System
Lot or serial number
Not Applicable
Model or catalog number
10010410001
Companies
- Manufacturer
-
Metran Co., Ltd.
2-12-18, Kawaguchi
Kawaguchi-Shi
332-0015
JAPAN