Device recall

Z-2025-2023: Philips Respironics V60 Ventilator-Intended to mechanically control or assist…

FDA device recall · Class II · DRE Medical Group Inc

Key facts

Recall number (Z-number) Z-2025-2023
Recall event 92448
Product Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
Product code MNT
Recalling firm DRE Medical Group Inc
Recall class Class II
Status Open, Classified
FEI number 1000122786

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)