Philips Respironics recalls Trilogy Evo and Trilogy Evo O2 devices with specific material numbers. These devices may cause barotrauma or breathing issues if used on patients under 10 kg due to missing contraindications in the safety statement.
The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.
Philips Respironics is recalling certain Trilogy Evo and Trilogy Evo O2 devices because they lack a critical safety warning about using them on patients under 10 kg. This could lead to serious breathing problems or injury if the device is used incorrectly on small patients.
The recalled devices do not include a warning that they should not be used on patients weighing less than 10 kg. If used on such patients, it can cause breathing difficulties, excessive carbon dioxide buildup, or lung injury.
Parents or caregivers of infants and young children under 10 kg who use these devices for breathing support are most at risk. Patients with specific medical conditions requiring the device may also be affected.
Check the device's material numbers listed in the recall notice: BL2110X15B, BR2110X18B, CA2110X12B, DE2100X13B, DE2110X13B, DS2100X11B, and other specific codes. These models were sold in various countries with different serial numbers.
Identify the device's material number from the list provided in the recall notice to confirm if it is affected.
Talk to your healthcare provider to determine if the device is safe for your child's weight and medical needs.
The devices lack a critical safety warning that they should not be used on patients weighing less than 10 kg, which could cause breathing problems or injury.
The affected models include Trilogy Evo and Trilogy Evo O2 with specific material numbers such as BL2110X15B, BR2110X18B, CA2110X12B, and others listed in the recall notice.
No, but you should check if your device is affected and consult your healthcare provider before using it on patients under 10 kg.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-0638-2024 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0638-2024 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.
