Device recall

Z-3111-2017: Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended…

FDA device recall · Class II · Toshiba American Medical Systems

Key facts

Recall number (Z-number) Z-3111-2017
Recall event 77888
Product Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head…
Product code MQB
Recalling firm Toshiba American Medical Systems
Recall class Class II
Status Terminated
Termination date Oct 23, 2020
510(k) numbers K122842
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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