Ventilator Instructions for Use Contain Translation Error in Korean Materials
Korean-language instructions for Trilogy Evo ventilators contain a mistranslation where 'invasive' was incorrectly rendered as 'noninvasive.' This error could lead to improper device configuration by Korean-speaking users.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall. Although no illnesses or injuries have been reported, the translation error in ventilator instructions creates a risk-of-harm situation where users could select incorrect ventilation modes, potentially causing patient harm.
Plain-English summary
The FDA is recalling Philips Respironics Trilogy Evo ventilator Instructions for Use distributed in Korea. The Korean-language instructions for models 1137823 (Evo Clinical) and 1137853 (Evo Caregiver) contain a translation error where the word 'invasive' was incorrectly rendered as 'noninvasive.'
This mistranslation could lead to confusion about the ventilator's mode of operation and improper device configuration by Korean-speaking users.
Approximately 1,581 units were distributed in Korea. Healthcare providers and patients using these devices should refer to the correct English-language instructions for accurate information about invasive and noninvasive ventilation modes. Users should contact Philips Respironics for corrected Korean-language materials.
The recalled product
- Product
- Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- translation-error
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Material No. KR2110X15B
- GTIN: 00606959055483
- Serial No. H30665832F44A
- H3066588656C6
- H306658946C0C
- H30665905F041
- H306659391045
- H30665956BC62
- H30665965A491
- H306659871D93
- H30665993426F
- H306660257A22
- H306660321745
- H30666039A996
- H306660506087
- H30666058ECCF
- H306660637874
- H30666068C6A7
- H3066608496DB
- H30666098456F
Distribution
Distribution scope not specified by the agency.
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