Device recall

Z-0295-2012: GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced…

FDA device recall · Class II · Varian Medical Systems, Inc.

Key facts

Recall number (Z-number) Z-0295-2012
Recall event 59856
Product GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH. Designed for brachytherapy intracavity treatments in areas such as cancer of the vagina, vaginal stump or rectum.
Product code JAQ
Recalling firm Varian Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date Dec 7, 2011
510(k) numbers K983436
FEI number 3000206172

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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