Device recall

Z-1849-2015: The VariSource iX series afterloader systems are computer controlled remote…

FDA device recall · Class II · Varian Medical Systems Inc

Key facts

Recall number (Z-number) Z-1849-2015
Recall event 71451
Product The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.
Product code JAQ
Recalling firm Varian Medical Systems Inc
Recall class Class II
Status Terminated
Termination date Sep 12, 2016
510(k) numbers K122236
FEI number 3011400544

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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