Class 1 Device Recall Newport Medical" HT70 and HT70 Plus Ventilators

• Date Initiated by Firm: March 30, 2017
• Date Posted: April 10, 2017
• Recall Status: Terminated on July 18, 2020
• Recall Number: Z-1874-2017
• Recall Event ID: 76891
• 510(K)Number: K111146 K090888
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: 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, pediatric and adult patients greater than or equal to 5 kg (11 lbs). The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
• Code Information: All Newport Medical HT70 and HT70- Plus Ventilators
• Recalling Firm/ Manufacturer: Newport Medical Instruments Inc; 1620 Sunflower Ave; Costa Mesa CA 92626-1513
• For Additional Information Contact: Catherine T. Wrenn.; 203-492-5415 Ext. 344
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 with questions were advised to contact the Technical Support Department immediately at 800-255-6774. For questions regarding this recall call 203-492-5415.
• Quantity in Commerce: 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, United Arab Emirates, United Kingdom Algeria, Armenia, Austria, Bahrain, Belarus, Belgium, Botswana Bulgaria, Cyprus, Czech Republic, Denmark, Egypt, Finland, France Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Kenya, Lebanon Lithuania, Macedonia, Malawi, Malta, Mauritius, Mozambique, Netherlands Norway, Oman, Poland, Portugal, Qatar, Republic of Moldova, Romania Saudi Arabia, Serbia, Slovakia, Sudan, Sweden, Switzerland, Tunisia Turkey, Uganda, Ukraine, United Kingdom, Yemen, and Zimbabwe
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK and Original Applicant = NEWPORT MEDICAL INSTRUMENTS, INC.