FDA recall Z-2106-2023

Philips Respironics, Inc. · Class II · device

Product

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".

Distribution

Foreign Distribution: Korea.

Key facts

Status
Ongoing
Initiation date
2023-05-25
Report date
2023-07-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Murrysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2106-2023