Device recall

Z-2083-2012: NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system…

FDA device recall · Class II · Philips And Neusoft Medical Systems Co., Ltd.

Key facts

Recall number (Z-number) Z-2083-2012
Recall event 62481
Product NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL…
Product code JAK
Recalling firm Philips And Neusoft Medical Systems Co., Ltd.
Recall class Class II
Status Terminated
Termination date Sep 17, 2012
510(k) numbers K090173, K092742
FEI number 3003575350

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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