FDAFDA · Food and drugs·Recall number Z-2290-2021
Trilogy Evo Universal, Product number DS2000X11B
Published August 25, 2021 · Recall initiated: July 26, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Respironics, Inc.
- Distributor
- Worldwide distribution - US nationwide distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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