Newport HT50 Ventilator (all Models)

Date posted by the FDA

Sept. 19, 2007

Status

Terminated

Filed by

Newport Medical Instruments Inc

Product

Newport HT50 Ventilator (all Models)

Reason

Battery Life: With use over time, the internal battery begins losing its ability to hold a charge resulting in shortened ventilator operation time. Specifically, Newport has received a number of reports concerning the internal battery not lasting as long as expected followed by ventilator shut down with less advance warning than when the battery was new.

Distribution pattern

Worldwide including USA, Algeria, Argentina, Armenia, Australia, Belgium, Bolivia, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote D' Ivoire, Croatia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, England, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Liechtenstein, Lithuania, Malaysia, Mexico, Netherlands, New Caldonia, New Zealand, Oman, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Switzerland, Syria, Taiwan, Thailand, Turkey, UAE, Ukraine, United Kingdom, Venuzuela, Yemen, and Zambia

Quantity

8,160

Codes and lots

All models, all serial numbers

Recall started

July 31, 2007

Device type

Ventilator, Continuous, Facility Use

Root cause (FDA)

Other

What the company told customers

An Important Medical Device Correction Letter was issued on September 14, 2007 as a short term fix. The firm has submitted a long term correction as a supplement to its 510 K which is pending review by FDA.

Recall number

Z-1192-2007

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1192-2007. The agency record governs; check it and the company before acting.