Device recall

Z-2896-2011: Aquilion One: Aquilion TSX-301B, 64 System, X-Ray, Tomography. Toshiba American…

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

Key facts

Recall number (Z-number) Z-2896-2011
Recall event 58031
Product Aquilion One: Aquilion TSX-301B, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning.
Product code JAK
Recalling firm Toshiba American Medical Systems Inc
Recall class Class II
Status Terminated
Termination date Aug 17, 2012
510(k) numbers K083282
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

Browse all FDA device recalls (products)