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Recall Observatory FDA recall evidence

Device product

Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B

Z-2288-2021

July 26, 2021

Class II

Product summary

Firm
Philips Respironics, Inc.
Event
Event 88333
Status
Ongoing
Classification
Class II
Quantity
101 (FEMA Stockpile Only); 21077 (OUS)
Official record key
device-enforcement:Z-2288-2021

Official wording

Reason: 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).

Code information: 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

Distribution pattern: Worldwide distribution - US nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).