Device recall

Z-1458-2011: The Panorama HFO system has the Traceable Item Identification (12NC): 9896 030…

FDA device recall · Class II · Philips Medical Systems North America Co. Phillips

Key facts

Recall number (Z-number) Z-1458-2011
Recall event 57561
Product The Panorama HFO system has the Traceable Item Identification (12NC): 9896 030 17741-SW R 2.5.1 (shipped as R 2.5.1, upgraded to R 2.5.3 via FCO). 9896 030 19641-SW R 2.5.3 9896 030 19861-SW R 2.6.1 9896 030 19862-SW R 2.6.1 9896 030 19863-SW R 2.6.3
Product code LNH
Recalling firm Philips Medical Systems North America Co. Phillips
Recall class Class II
Status Terminated
Termination date Aug 10, 2011
510(k) numbers K041602
FEI number 1000524572

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)