Nucletron Adapter and Transfer Guide Tube, part number AL 13005000, a component used with the VariSource" IX HDR Afterlo
FDA device recall Z-1199-2012 · posted 2012-03-12 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients.
- Action taken
- Varian Medical Systems sent an Urgent Medical Device Correction - Urgent Field Safety Notice letter dated January 5, 2012 to all affected consignees. The letter identified the affected products, description of problem and recommended user actions to be taken. Consignees were requested to cease use of the affected products and contact Varian BrachyTherapy Helpdesk immediately to arrange return of their affected parts. Consignees were requested to return the enclosed proof of notification form. Consignees were instructed to advise the appropriate personnel working in their radiotherapy department of the content of this letter. For future reference, this document will be posted to the Varian Customer Support website: http://www.MyVarian.com. For further clarification contact your local Varian District or Regional Manager.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 122 total units
- Distribution
- Worldwide Distribution - USA (nationwide) Including the states of CA, FL, IN, KY, MI, MN, MO, OH, TX, VA and the countries of Canada, Japan and Sweden.
- Date initiated
- 2012-01-05
- Date posted
- 2012-03-12
- Date terminated
- 2012-11-21
- Location
- Charlottesville, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARISOURCE IX HDR AFTERLOADER (K071467) | Varian Medical Systems, Inc. | 2007-07-16 |