FDA Medical Device Recalls (openFDA)
Respironics, Inc.: NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310
- Recall number
- Z-1191-06
- Recalling firm
- Respironics, Inc.
- Product
- NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310
- Status
- Terminated
- Initiated
- 2005-09-19
- Posted
- 2006-07-01
- Terminated
- 2006-07-11
- Reason
- Gas input pressures over 62 psi may cause CPAP pressure oscillation
- Root cause
- Other
- Action
- The recalling firm issued a recall letter to their customers dated 9/19/05 informing them of the problem and the corrective action. (fitting unit with external 50 psi pressure regulator for both air and oxygen)
- Quantity
- 232 units
- Distribution
- World wide (including medical facilities in AZ, CA, CO, GA, IA, IL, MA, MD, MN, MO, NC, NE, NH, NJ, OH, OK, OR, PA, PR, TN, TX, VA, WI, and WV. Japan, Ireland, Great Britain, Sweden, Portugal, France, Chile, Argentina, Hong Kong, South Africa, Greece, Egypt, Saudia Arabia, Norway, Spain, Belgium and Canada
- Lot, serial or model codes
- Serial numbers 5310050616-01, 5310050616-02, 5310050621-01
- 510(k) numbers
- ["K040862"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2518422
- Firm city
- Murrysville
- Firm state
- PA
- 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