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Philips Respironics, Inc. recalls Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
Recalled July 12, 2023 · FDA recall Z-2106-2023 · Philips Respironics
Hazard
There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive". · FDA Class II
Units
1,581 units
Sold at
Foreign Distribution: Korea.
Description
There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
Product
Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
Manufacturer(s)
Philips Respironics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →