Device recall

Z-0752-2016: INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems

FDA device recall · Class II · Toshiba American Medical Systems Inc

Key facts

Recall number (Z-number) Z-0752-2016
Recall event 73078
Product INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Product code OWB
Recalling firm Toshiba American Medical Systems Inc
Recall class Class II
Status Terminated
Termination date May 18, 2016
510(k) numbers K120073, K133535
FEI number 2020563

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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