FDA Medical Device Recalls (openFDA)
Newport Medical Instruments Inc: Newport HT50 All Purpose Ventilator
- Recall number
- Z-1375-05
- Recalling firm
- Newport Medical Instruments Inc
- Product
- Newport HT50 All Purpose Ventilator
- Status
- Terminated
- Initiated
- 2005-10-29
- Posted
- 2005-08-17
- Terminated
- 2012-08-02
- Reason
- Lack of alarm prior to shutdown.
- Root cause
- Other
- Action
- Notice of Field Correction was sent to consignees dated 10/29/2004. A second notice was sent 12/20/04 announcing that materials for conducting an upgrade were being sent which included a manual insert and brochure regarding the battery. Also request was made to return products as they are available. Notice was sent 12/20/04 that field correction kits were available for order. Recall is ongoing.
- Quantity
- 3654
- Distribution
- Nationwide and Argentina, Australia, Bangledesh, Belgium, Bolivia, Brazil, Bulgria, Canada, Chile, Hong Kong, Colombia, Croatia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, France, Germany, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Liechtenstein, Lithuania, Malaysia, Mexico, Netherlands, New Caldonia, Paraguay, Philipines, Poland, Portugal, Quatar, Republic of South Africa, Russia, Saudi Arabia, Singapore, Slovenia, South Korea, Sri Lanka, Sultanate of Oman, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen Republic.
- Lot, serial or model codes
- All serial numbers. Products are identified by serial numbers on back of ventilators. Manufacturer states serial numbers of ventilators involved in field correction may be obtained through shipping records.
- 510(k) numbers
- ["K992133"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2023050
- Firm city
- Costa Mesa
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28