Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.
FDA Recall Z-1324-2013 · Posted 2013-05-15
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Recalling FirmVarian Medical Systems, Inc.
Recall StatusTerminated
Product CodeJAQ
Date Initiated0013-04-11
Date Terminated2014-01-13
Product Quantity21 devices
Reason for Recall
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
Firm Action
Varian Medical Systems, Inc. notified customers of the recall with 'Urgent Medical Device Correction Urgent Field Safety Notice," dated 4/11/13, and delivered by mail to customers. The notice identified the product, problem, and instructions for the customers. Varian Medical Systems, Inc. informed customers of the possible malfunction of the GM11004150 Segmented Cylinder Applicator Set for pulsed dose rate brachytherapy treatment, with codes H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387. The notice instructed customers to cease use of the Segmented Cylinder Applicator Set and return the devices along with a completed proof of notification form (included with the recall notice) to the recalling firm.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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