Philips Respironics recalls Trilogy EV300 ventilators with specific software versions due to potential pressure increases affecting infants and children. Affected units may require software updates to prevent safety 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 certain Trilogy EV300 ventilators that have software issues causing potential pressure increases. This could affect infants and children using the device, as the pressure changes might lead to breathing difficulties.
The device has two software issues that can cause pressure increases in the breathing system. One issue affects infant/pediatric calibration, while the other causes continuous pressure drift during use. These changes could lead to breathing difficulties for children.
Parents or caregivers of infants and children using the recalled Trilogy EV300 ventilators are most at risk. The affected units are identified by specific product numbers and software versions.
Check the product numbers: CA2200X12B, DS2200X11B, FX2200X15B, or IN2200X15B. Also look for software versions 1.02.01.00 through 1.06.02 on the device.
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.
Reach out to Philips Respironics for guidance on software updates or other remedies if your device is affected.
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 numbers: CA2200X12B, DS2200X11B, FX2200X15B, or IN2200X15B. Also verify the software version matches the listed versions.
No, the recall does not require immediate discontinuation. Affected users should check for software updates or contact Philips Respironics for guidance.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-2289-2021 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-2289-2021 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.
