FDA-Device2023-07-12Class II
Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
Philips Respironics, Inc.
Hazard
There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
Sold states
Foreign Distribution: Korea.
Affected count
1,581 units
Manufactured in
1001 Murry Ridge Ln, N/A, Murrysville, PA, United States
Products
Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2106-2023Don't want to check this manually?
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