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Terminated

Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.

FDA Recall Z-1829-2015 · Posted 2015-06-23

Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeJAQ
Date Initiated2015-05-18
Date Terminated2016-01-26
Product Quantity46

Reason for Recall

Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06. The actual dose rate of the applicator is approximately 14% higher than the rate published within the IFU. Use of the dose rate as provided by the IFU without modification or independent confirmat

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

Process design

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123815SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONEVarian Medical Systems, Inc. · 2013-03-11

Official Source

View FDA Recall →

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

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