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Terminated

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.

FDA Recall Z-1849-2015 · Posted 2015-06-26

Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeJAQ
Date Initiated2015-05-18
Date Terminated2016-09-12
Product Quantity55

Reason for Recall

After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The application freeze issue affects only the systems equipped with magnetic Hard Disk Drives (HDD).

Firm Action

All the consignees affected by this recall will be notified by: The Urgent Medical Device Correction Letter/ Field Safety Notification will be distributed to all affected users, with a description of the problem. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. Additionally, the letter will be posted to the customer support site: http:/ /www.MyVarian.com.

Root Cause

Software Design Change

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122236VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADERVarian Medical Systems, Inc. · 2012-11-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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