FDA-Device2021-08-25Class II
Trilogy Evo Universal, Product number DS2000X11B
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
10,000 (FEMA Stockpile Only)
Manufactured in
1001 Murry Ridge Ln, N/A, Murrysville, PA, United States
Products
Trilogy Evo Universal, Product number DS2000X11B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2290-2021Don't want to check this manually?
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