Product Wiki · Recalls · Health Canada — Medical Devices

High Frequency Oscillatory Ventilators Models 3100A and 3100B… — recall 50885

Health Canada — Medical Devices · Canada · 2013-12-17 · Type II

As described by Health Canada — Medical Devices: High Frequency Oscillatory Ventilators Models 3100A and 3100B (2013-03-11)

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Agency
Health Canada — Medical Devices
Recall identifier
50885
Date of alert
2013-12-17
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: There have been reports of failures of Cap / Diaphragm assemblies. Specific lots of Cap / Diaphragm assemblies used with 3100A or 3100B high frequency oscillatory ventillators could fail thereby preventing the targeted mean airway pressure (39 - 43 cm H20) being reached during system calibration test set up prior to being used on patients.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/high-frequency-oscillatory-ven

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