FDA Device recall Z-0884-2023
Philips Garbin Ventilator, Model Number 1058180B
- FDA Device
- Class I
- ongoing
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class I recall of Philips Garbin Ventilator, Model Number 1058180B by Philips Respironics, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0884-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-12-07 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Respironics |
| Distribution | US |
Product
Philips Garbin Ventilator, Model Number 1058180B
Reason
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.
Identifiers
| code_info | UDI: 00606959429338; Serial Numbers: GV119100314 GV118011626 GV117030343 GV117020301 GV11910210D GV117060237 GV11807062D GV119070802 GV11605061E |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0884-2023%22
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