Z-1192-2007

Newport HT50 Ventilator (all Models)

Name: Z-1192-2007 Newport HT50 Ventilator (all Models)
Creator: Newport Medical Instruments Inc
Published: 2007-07-31
License: https://open.fda.gov/license/

Newport Medical Instruments, Inc. / initiated 2007-07-31 / Terminated

FDA source

Newport Medical Instruments Inc began a recall of Newport HT50 Ventilator (all Models) on 2007-07-31. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1192-2007
Status: Terminated
Initiated: 2007-07-31
Posted: 2007-09-19
Terminated: 2012-03-21
Recalling firm: Newport Medical Instruments, Inc.
Product: Newport HT50 Ventilator (all Models)
Product code: CBK Ventilator, Continuous, Facility Use
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 root 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
Product codes and lots: All models, all serial numbers

Product code CBK

K992133Class IINewport Ht50 Ventilator with Humidifier Ht50-H, Newport Ht50 Ventilator without Humidifier, Ht50-H1, Newport Ht50 VentilNewport Medical Instruments, Inc. / cleared 2000-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)