Device recall

Z-0368-2007: Allura FD 10 FC, X-Ray System, angiographic - a monoplane, digital Allura FD…

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

Key facts

Recall number (Z-number) Z-0368-2007
Recall event 37012
Product Allura FD 10 FC, X-Ray System, angiographic - a monoplane, digital Allura FD (flat detector) with a 10' Image Intensifier (II).
Product code IZI
Recalling firm Philips Medical Systems North America Co. Phillips
Recall class Class II
Status Terminated
Termination date Oct 14, 2011
510(k) numbers K022899
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

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