Class 2 Device Recall Newport HT50

• Date Initiated by Firm: July 31, 2007
• Date Posted: September 19, 2007
• Recall Status: Terminated on March 21, 2012
• Recall Number: Z-1192-2007
• Recall Event ID: 38630
• 510(K)Number: K992133
• Product Classification: Ventilator - Product Code CBK
• Product: Newport HT50 Ventilator (all Models)
• Code Information: All models, all serial numbers
• Recalling Firm/ Manufacturer: Newport Medical Instruments Inc; 1620 Sunflower Ave; Costa Mesa CA 92626-1513
• For Additional Information Contact: Richard Waters; 714-427-5811 Ext. 120
• Manufacturer 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.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 8,160
• Distribution: 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
• 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