Device recall

Z-0494-2022: Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257…

FDA device recall · Class I · Philips Respironics, Inc.

Key facts

Recall number (Z-number) Z-0494-2022
Recall event 89276
Product Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients…
Product code CBK
Recalling firm Philips Respironics, Inc.
Recall class Class I
Status Open, Classified
510(k) numbers K181166, K181170
FEI number 2518422

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)