Drug recall
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be…
FDA recall event 89584 · Class I · Philips Respironics, Inc.
Key facts
| Event ID | 89584 |
|---|---|
| Recall numbers | Z-0785-2022 |
| Recalling firm | Philips Respironics, Inc. |
| Product type | Devices |
| Products | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and… |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into… |
| Initiation date | Jun 12, 2018 |
| Report date | Mar 30, 2022 |
| City | Murrysville |
| State | PA |
| Country | United States |
| FEI number | 2518422 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: