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U.S. Department of Health and Human Services

Class 2 Device Recall Newport HT50

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  Class 2 Device Recall Newport HT50 see related information
Date Initiated by Firm July 31, 2007
Date Posted September 19, 2007
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = NEWPORT MEDICAL INSTRUMENTS, INC.
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