Device recall

Z-0882-2023: Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260…

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

Key facts

Recall number (Z-number) Z-0882-2023
Recall event 91293
Product Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096, KR1054096, R1054655TP…
Product code CBK
Recalling firm Philips Respironics, Inc.
Recall class Class I
Status Open, Classified
510(k) numbers K083526
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)