Device recall

Z-0182-2012: Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A…

FDA device recall · Class II · Philips Medical Systems

Key facts

Recall number (Z-number) Z-0182-2012
Recall event 60036
Product Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period A nuclear medicine image display and processing application suite that provided software applications used to process analyze and display medical images/data.
Product code LLZ
Recalling firm Philips Medical Systems
Recall class Class II
Status Terminated
Termination date Jan 30, 2013
510(k) numbers K012009
FEI number 1525965

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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