CLASS I ONGOING Device recall · Reported 18 Jan 2023 · FDA Enforcement Report
Philips Garbin Ventilator recalled by Philips Respironics
Philips Respironics is recalling Philips Garbin Ventilator, distributed nationwide in the US. The recall was initiated on 7 Dec 2022 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0884-2023
- FDA event ID
- 91293
- Recalling firm
- Philips Respironics, Murrysville, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 7 Dec 2022
- FDA classified
- 6 Jan 2023
- Reported
- 18 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- CPAP & Ventilators
Timeline
| 7 Dec 2022 | Recall initiated by company | |
| 6 Jan 2023 | Classified by FDA | +30 days |
| 18 Jan 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Philips Garbin Ventilator, Model Number 1058180B
Where it was distributed
US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.
Questions about this recall
Is Philips Garbin Ventilator recalled?
Yes. Philips Respironics recalled Philips Garbin Ventilator on 7 Dec 2022. The recall is Class I and its status is Ongoing. Recall number Z-0884-2023.
Why was it recalled?
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.
Which lots are affected?
UDI: 00606959429338; Serial Numbers: GV119100314 GV118011626 GV117030343 GV117020301 GV11910210D GV117060237 GV11807062D GV119070802 GV11605061E
Where was it sold?
US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips Respironics
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Trilogy Evo recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
| Device | CLASS I | Trilogy EV300 recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
| Device | CLASS I | Trilogy Evo Universal recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
| Device | CLASS I | Trilogy Evo O2 recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
| Device | CLASS I | Trilogy Evo recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
Other CPAP & Ventilators recalls
All 551| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |
| Device | CLASS I | Giraffe Stand-alone Infant Resuscitation System recalled by Datex-Ohmeda | Datex-Ohmeda | Device Malfunction | WI |