Philips Respironics recalls Trilogy Evo Universal devices with specific software versions due to potential pressure increases in infants and children. Affected units may require software updates to prevent risks.
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).
Philips Respironics is recalling Trilogy Evo Universal devices with certain software versions because they may cause pressure increases in infants and children. This could lead to health risks if the device malfunctions.
The device has two software issues that could cause pressure increases in infants and children. These issues may lead to health risks if the device malfunctions during use.
Parents or caregivers of infants and children using the Trilogy Evo Universal device with the listed software versions are most at risk. The recall affects specific models sold with certain software updates.
Check the product number DS2000X11B and software versions 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, or 1.06.02. The device is sold by Philips Respironics.
Review the software version on your device to see if it matches the listed versions: 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, or 1.06.02.
The affected software versions are 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.
Check the product number DS2000X11B and software versions listed above. The device is sold by Philips Respironics.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-2290-2021 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-2290-2021 from Philips Respironics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
