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Philips Respironics, Inc. recalls Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Recalled August 25, 2021 · FDA recall Z-2289-2021 · Philips Respironics
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). · FDA Class II
Units
18936 (US); 4659 (OUS)
Sold at
Worldwide distribution - US nationwide distribution.
Description
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).
Product
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Manufacturer(s)
Philips Respironics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →