Terminated

Newport HT50 Ventilator (all Models)

FDA Recall Z-1192-2007 · Posted 2007-09-19

Recalling FirmNewport Medical Instruments Inc

Recall StatusTerminated

Product CodeCBK

Date Initiated2007-07-31

Date Terminated2012-03-21

Product Quantity8,160

Reason for Recall

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.

Firm Action

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.

Root Cause

Other

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992133NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTILNewport Medical Instruments, Inc. · 2000-08-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.