Recall Z-1874-2017 ยท CBK Ventilator, Continuous, Facility Use
Newport Medical Instruments Inc
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, p
| Date | Apr 10, 2017 (initiated Mar 30, 2017) |
| Status | Terminated |
| Reason | Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm. |
| Root cause | Software in the Use Environment |
| Action | Medtronic sent an Urgent Field Corrective Action Notice dated April 3, 2017, to all consignees via Federal Express or certified mail. The letter informed consignees of the remote potential for ventilator reset without accompanying alarm and the actions they should take. Customers were requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. Customers were also advised that a software service update will be available in May 2017 to address this issue. Medtronic issued a Press Release related to this voluntary field action on April 5, 2017. Consignees wit |
| Quantity | 12,966 |
| Distribution | Worldwide Distribution - US (Nationwide) Internationally to Canada, Australia, Brazil, Japan, Korea, Mexico, Bahrain, Egypt, Greece Hungary, Ireland, Israel, Jordan, Kazakhstan, Lithuania, Mauritius Namibia, Norway, Pakistan, Poland, Qatar, Romania, Russian Federation South Africa, Spain, Turkey, |
| FDA record | Open on fda.gov |