Device recall

Z-1665-2011: TSX-301A: AQUILION ONE System AQUILION ONE is a multislice CT system that…

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

Key facts

Recall number (Z-number) Z-1665-2011
Recall event 56407
Product TSX-301A: AQUILION ONE System AQUILION ONE is a multislice CT system that supports whole body scanning. The system supports simultaneous data acquisitions of 320 slices using the Selectable Slice-thickness Multi-row Detector.
Product code JAK
Recalling firm Toshiba American Medical Systems Inc
Recall class Class II
Status Terminated
Termination date Apr 5, 2011
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

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