Device recall

Z-0664-05: Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland…

FDA device recall · Class II · Nellcor Puritan Bennett

Key facts

Recall number (Z-number) Z-0664-05
Recall event 31271
Product Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.
Product code DQA
Recalling firm Nellcor Puritan Bennett
Recall class Class II
Status Terminated
Termination date May 15, 2006
510(k) numbers K012891
FEI number 2936999

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)