Device recall

Z-0994-2013: Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for…

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

Key facts

Recall number (Z-number) Z-0994-2013
Recall event 64674
Product Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
Product code MQB
Recalling firm Toshiba American Medical Systems Inc
Recall class Class II
Status Terminated
Termination date Mar 26, 2013
510(k) numbers K052884, K113052, K120073
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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