Recall Z-0785-2022 ยท CBK Ventilator, Continuous, Facility Use
Philips Respironics, Inc.
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 gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
| Date | Jun 12, 2018 |
| Status | Open, Classified |
| Reason | 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 particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices. |
| Root cause | Device Design |
| Action | 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 particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices. A Field Communication for Trilogy Preventive Maintenance Update was distributed to customers 6/12/18. PRODUCT(S) AFFECTED All Trilogy models with Inlet Air Path Assembly PURPOSE / SCOPE This Field Communication announces: " The addition of the rep |
| Quantity | 229,353 devices |
| Distribution | Global Distribution. US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111610 | TRILOGY SERIES VENTILATOR WITH OXIMETRY Respironics, Inc., Oct 14, 2011 |