Recall Z-1324-2013 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems, Inc.
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.
| Date | May 15, 2013 (initiated Apr 11, 13) |
| Status | Terminated |
| Reason | Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target. |
| Root cause | Device Design |
| 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 Cylinde |
| Quantity | 21 devices |
| Distribution | Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.