Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
FDA device recall Z-1829-2015 · posted 2015-06-23 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- 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
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 46
- Distribution
- Worldwide Distribution.
- Date initiated
- 2015-05-18
- Date posted
- 2015-06-23
- Date terminated
- 2016-01-26
- Location
- Charlottesville, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE (K123815) | Varian Medical Systems, Inc. | 2013-03-11 |