FDA-Device2021-08-25Class II
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Philips Respironics, Inc.
Hazard
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
Sold states
Worldwide distribution - US nationwide distribution.
Affected count
18936 (US); 4659 (OUS)
Manufactured in
1001 Murry Ridge Ln, N/A, Murrysville, PA, United States
Products
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2289-2021Don't want to check this manually?
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