Data Foundry

Medical device recalls 2023

Philips Trilogy 200 Ventilator — Class I medical device recall Z-0883-2023

Ongoing recall by Philips Respironics, Inc., reported 2023-01-18, distributed nationwide. The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may sepa

Recall numberZ-0883-2023
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips Respironics, Inc., Murrysville, PA, United States
Recall initiated2022-12-07
Classified2023-01-06
Reported by FDA2023-01-18
DistributedNationwide (US)
Countries outside the USAU, BR, CA, CN, DE, JP, KR
Quantity537 devices
UPC / GTIN / UDI-DI00606959033986, 00606959033993, 00606959429147, 00606959429154, 00606959429185, 00606959429208, 00606959429260, 00606959429444, 00606959429475, 00606959429611, 00606959429710
Serial numbersTV210072214, TV210072245, TV210081103, TV210082301, TV210092106, TV210092113, TV210102509, TV210110321, TV211051303, TV211060124, TV211060304, TV211060309, TV211060320, TV211080213, TV211092124, TV211092126, TV211113009, TV212020645, TV212022810, TV212031340, TV212041012, TV212041013, TV212051047, TV212051425, TV212062243 and 475 more
Model numbers1032800, 1032804B, 1040005, 1040005B, CA1032800, CA1032800B, KO1032800, R1032804B, R1032804TP, R1032804TPV, U1040005, U1040005B

Product

Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B

Reason for recall

The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0883-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.