medical Class II Updated 2021-08-25

Philips Respironics, Inc. recalls Trilogy Evo Universal, Product number DS2000X11B

Recalled Product

Trilogy Evo Universal, Product number DS2000X11B

Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software version numbers 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, and 1.06.02
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