Recall Z-1324-2013
Varian Medical Systems, Inc. · initiated April 11, 0013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387
Reason for recall
Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-1324-2013
- Initiated
- April 11, 0013
- Posted by FDA
- May 15, 2013
- Terminated
- January 13, 2014
- Product code
- JAQ – System, Applicator, Radionuclide, Remote-Controlled
- Quantity
- 21 devices
- Distribution
- Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.
- Recalling firm
- Varian Medical Systems, Inc., Charlottesville, VA