Recall Z-1829-2015
Varian Medical Systems Inc · initiated May 18, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Codes / lots: JAQ
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
FDA-determined cause: Process design
Action taken
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.
Details
- Recall number
- Z-1829-2015
- Initiated
- May 18, 2015
- Posted by FDA
- June 23, 2015
- Terminated
- January 26, 2016
- Product code
- JAQ – System, Applicator, Radionuclide, Remote-Controlled
- Quantity
- 46
- Distribution
- Worldwide Distribution.
- Recalling firm
- Varian Medical Systems Inc, Charlottesville, VA