Device recall

Z-3205-2011: PCR Eleva Radiological Image Processing System with software R.1.2 Philips…

FDA device recall · Class II · Philips Healthcare Inc.

Key facts

Recall number (Z-number) Z-3205-2011
Recall event 59473
Product PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc. A computed radiography image processing system.
Product code LLZ
Recalling firm Philips Healthcare Inc.
Recall class Class II
Status Terminated
Termination date Jan 12, 2017
510(k) numbers K964124
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)