medical Class II Updated 2021-08-25

Philips Respironics, Inc. recalls Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX220

Recalled Product

Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B

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
View official government recall

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