Philips Respironics recalls Trilogy Evo O2 devices with specific product numbers and software versions due to potential pressure increases that could affect infants and children.
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 certain Trilogy Evo O2 oxygen devices because software issues may cause pressure increases. This could be harmful to infants and children using the device.
The devices have two software issues that could cause pressure increases: one related to infant/pediatric EFS calibration and another to pressure drift during continuous use. These issues may lead to unsafe oxygen delivery levels for infants and children.
Parents and caregivers of infants and children using the recalled Trilogy Evo O2 oxygen devices are most at risk. The specific product numbers and software versions listed in the recall affect users with these models.
Check if your Trilogy Evo O2 device has product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, or software versions 1.02.01.00 through 1.06.02.
Review your device's product number and software version to confirm if it matches the recalled models listed in the notice.
Philips Respironics identified two software issues that could cause pressure increases in the device, which may be harmful to infants and children.
Software versions 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 are affected.
The recall notice does not specify a remedy or action steps for affected users.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-2288-2021 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-2288-2021 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.
