FDA Medical Device Recalls (openFDA)
Philips Respironics, Inc.: Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Recall number
- Z-1616-2026
- Recalling firm
- Philips Respironics, Inc.
- Product
- Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Status
- Open, Classified
- Initiated
- 2026-03-02
- Posted
- 2026-03-26
- Terminated
- not on file
- Reason
- Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
- Root cause
- Under Investigation by firm
- Action
- An UPDATED: "URGENT FIELD SAFETY NOTICE" dated 3/2/26 was mailed to consignees containing recall information for three different failure modes that can be experienced in all Trilogy Evo, Trilogy EVO O2, Trilogy Evo Universal, and Trilogy EV300 devices. The firm identified that using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. This can lead to under-delivery of therapy to the patient. Consignees are being instructed to update all devices with software version 1.05.15.00 through the My Philips for Professionals and In Center websites. The provided Appendix B contains the required instructions. Consignees are also instructed to review the latest version of the User Manual Addendum, communicate the safety notice to all in their organization who interact with affect devices, and forward the notice to those who received product that was further distributed. Consignees are to stop all use of non-pneumatic nebulizers, including vibrating mesh nebulizers, with all affected devices. Distributors should notify their customers of this recall with the provided notice and response form. DME and Homecare Customers can contact 1-800-345-6443 (option 2, option 1) for assistance. Hospital Customers can contact 1-800-722-9377 (option 2) for assistance.
- Quantity
- 113,717 units
- Distribution
- Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Georgia, French Guiana, Gibraltar, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jersey, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Lithuania, Morocco, Montenegro, North Macedonia, Myanmar, Martinique, Malta, Mexico, Malaysia, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, French Polynesia, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, R¿union, Romania, Serbia, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Vietnam, Mayotte, South Africa, Zimbabwe.
- Lot, serial or model codes
- All Model No.; All UDI; All Serial No.
- 510(k) numbers
- not on file
- 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