Device recall

Z-0184-2007: M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax…

FDA device recall · Class II · Philips Medical Systems

Key facts

Recall number (Z-number) Z-0184-2007
Recall event 36489
Product M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used with the IntelliVue or M3/M4 patient monitor M1002
Product code DQA
Recalling firm Philips Medical Systems
Recall class Class II
Status Terminated
Termination date Aug 11, 2020
510(k) numbers K033715
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)