Z-1874-2017Class I

Newport Medical HT70 and HT70- Plus Ventilators, Rx Only

Name: Z-1874-2017 Newport Medical HT70 and HT70- Plus Ventilators, Rx Only
Creator: Newport Medical Instruments Inc
Published: 2017-03-30
License: https://open.fda.gov/license/

Newport Medical Instruments, Inc. / initiated 2017-03-30 / Terminated / root cause: software

FDA source

Newport Medical Instruments Inc began a recall of Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or... on 2017-03-30. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1874-2017
Classification: Class I
Status: Terminated
Initiated: 2017-03-30
Posted: 2017-04-10
Terminated: 2020-07-18
Recalling firm: Newport Medical Instruments, Inc.
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.
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: software
FDA 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 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
Product codes and lots: All Newport Medical HT70 and HT70- Plus Ventilators

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1874-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1874-2017	Class I	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-01

Product code CBK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)