Device recall

Z-1865-2011: Axxent Flexishield Mini To shape the beam from a low energy radiation therapy…

FDA device recall · Class I · Xoft Inc.

Key facts

Recall number (Z-number) Z-1865-2011
Recall event 57890
Product Axxent Flexishield Mini To shape the beam from a low energy radiation therapy source up to 50kVp.
Product code IXI
Recalling firm Xoft Inc.
Recall class Class I
Status Terminated
Termination date Jun 8, 2011
510(k) numbers K090417
FEI number 3005594788

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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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