Device recall

Z-2976-2011: Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper…

FDA device recall · Class II · Philips Healthcare Inc.

Key facts

Recall number (Z-number) Z-2976-2011
Recall event 59296
Product Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl. OR table) Allura Xper FD20- High resolution fixed-x ray Allura Xper FD20/10 Allura Xper FD20/20 Allura CV20 The Allura Xper F010, FD10/10, FD20, FD20/10 and FD20/20 Use From Labeling): is intended for use in…
Product code IZI
Recalling firm Philips Healthcare Inc.
Recall class Class II
Status Terminated
Termination date May 14, 2014
510(k) numbers K031333, K033737, K041949
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)