Device recall

Z-2337-2020: Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The…

FDA device recall · Class II · Philips North America, LLC

Key facts

Recall number (Z-number) Z-2337-2020
Recall event 85729
Product Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intuitive operation.
Product code DPS
Recalling firm Philips North America, LLC
Recall class Class II
Status Terminated
Termination date Aug 25, 2020
510(k) numbers K090483
FEI number 1218950

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)