Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intend

FDA device recall Z-1874-2017 · posted 2017-04-10 · Terminated

Recall details

Recalling firm

Newport Medical Instruments Inc

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.

Action taken

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.

Root cause

Software in the Use Environment

Status

Terminated

Product code

CBK

Quantity affected

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 N

Date initiated

2017-03-30

Date posted

2017-04-10

Date terminated

2020-07-18

Location

Costa Mesa, CA

Related 510(k) clearances