Recall Z-2106-2023— Philips Respironics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Philips Respironics, Inc., initiated 2023-05-25. It names one FDA 510(k) clearance: K181166. Product: Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use. Reason: There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive"..
- Recalling firm
- Philips Respironics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-25
- Firm location
- Murrysville, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
Reason for recall
There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
Data sourced from openFDA. This site is unofficial and independent of the FDA.