Device recall

Z-0623-2009: Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software…

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

Key facts

Recall number (Z-number) Z-0623-2009
Recall event 50748
Product Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher Used for general R/F, fluoroscopy, radiography, and angiography examinations.
Product code KPR
Recalling firm Philips Medical Systems North America Co. Phillips
Recall class Class II
Status Terminated
Termination date Sep 28, 2010
510(k) numbers K050151
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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