Device recall

Z-0533-06: Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the…

FDA device recall · Class II · Toshiba American Med Sys Inc

Key facts

Recall number (Z-number) Z-0533-06
Recall event 34955
Product Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device
Product code LLZ
Recalling firm Toshiba American Med Sys Inc
Recall class Class II
Status Terminated
Termination date Feb 29, 2012
510(k) numbers K961307
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)