Device recall

Z-1369-2011: Allura XPER FD 20 and and Allura CV20; Allura XPER FD 10 and Field Extension for…

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

Key facts

Recall number (Z-number) Z-1369-2011
Recall event 57106
Product Allura XPER FD 20 and and Allura CV20; Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura CV20. Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
Product code IZI
Recalling firm Philips Medical Systems North America Co. Phillips
Recall class Class II
Status Terminated
Termination date Jul 21, 2011
FEI number 1000524572

At a glance

  • None 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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