Philips Respironics recalls Korean instructions for use for Trilogy Evo, Evo Clinical and Evo Caregiver models due to incorrect translation of 'invasive' as 'noninvasive' in the instructions.
There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
Philips Respironics is recalling Korean-language instructions for use for Trilogy Evo, Evo Clinical, and Evo Caregiver models because the word 'invasive' was incorrectly translated as 'noninvasive' in the instructions. This translation error could lead to improper use of the medical device.
The instructions incorrectly translate the medical term 'invasive' as 'noninvasive', which could lead to misunderstandings about how to safely use the device. This might result in improper setup or operation, but it does not pose an immediate safety risk.
Users of the Korean-language instructions for Trilogy Evo, Evo Clinical, and Evo Caregiver models. Most at risk are those who rely on these instructions for proper device use.
Check for the Korean instructions for use with model numbers Trilogy Evo, Evo Clinical, or Evo Caregiver. The product includes serial numbers starting with H30665 or H30670 (e.g., H30665832F44A, H30670227AC56).
Check the Korean instructions for use for Trilogy Evo, Evo Clinical, or Evo Caregiver models to confirm the translation error.
The recall was issued because the Korean instructions for use incorrectly translated the medical term 'invasive' as 'noninvasive', which could lead to improper device use.
No, the recall only involves the instructions for use, not the actual device. The device itself is not affected.
Check for the Korean instructions with model numbers Trilogy Evo, Evo Clinical, or Evo Caregiver. The serial numbers start with H30665 or H30670 (e.g., H30665832F44A, H30670227AC56).
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-2106-2023 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-2106-2023 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.
