Trilogy 100 Ventilator

• 2 recalls, same reason

  • Ongoing Z-0882-2023 FDA Class I ·initiated 7 Dec 2022
  • Ongoing Z-0884-2023 FDA Class I ·initiated 7 Dec 2022

  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.

• • Ongoing Z-1956-2021 FDA Class I ·initiated 14 Jun 2021

  The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

• • Terminated Z-1065-2016 FDA Class II ·initiated 18 Jan 2016

  Software Issue

• • Terminated Z-1143-2014 FDA Class I ·initiated 11 Feb 2014

  Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients.

• • Terminated Z-2024-2012 FDA Class I ·initiated 27 Apr 2012

  The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.

• • Terminated Z-0296-2012 FDA Unclassified (pre-2012) ·initiated 11 Oct 2011

  Trilogy 100, 200 and 202 units are being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the inside of the blower housing/impeller enclosure. This may impact therapy.

• • Terminated Z-1896-2010 FDA Unclassified (pre-2012) ·initiated 10 Jun 2010

  It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event.

510(k) Number

K083526 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Respironics Inc., Sleep & Home Respiratory Group →