Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used d

FDA device recall Z-1324-2013 · posted 2013-05-15 · Terminated

Recall details

Recalling firm

Varian Medical Systems, Inc.

Reason for recall

Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.

Action taken

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

Status

Terminated

Product code

JAQ

Quantity affected

21 devices

Distribution

Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.

Date initiated

0013-04-11

Date posted

2013-05-15

Date terminated

2014-01-13

Location

Charlottesville, VA