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Philips Respironics, Inc. recalls Trilogy Evo Universal, Product number DS2000X11B
Recalled August 25, 2021 · FDA recall Z-2290-2021 · 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
10,000 (FEMA Stockpile Only)
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 Evo Universal, Product number DS2000X11B
Manufacturer(s)
Philips Respironics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →