Philips Garbin Ventilator, Model Number 1058180B
FDA Recall #Z-0884-2023 — Class I — December 7, 2022
Product Description
Philips Garbin Ventilator, Model Number 1058180B
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.
Recalling Firm
Philips Respironics, Inc. — Murrysville, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
9
Distribution
US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.
Code Information
UDI: 00606959429338; Serial Numbers: GV119100314 GV118011626 GV117030343 GV117020301 GV11910210D GV117060237 GV11807062D GV119070802 GV11605061E
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated