Recall Z-0760-2013 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems, Inc.
Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
| Date | Jan 31, 2013 (initiated Apr 12, 2012) |
| Status | Terminated |
| Reason | A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions. |
| Root cause | Component design/selection |
| Action | Varian Medical Systems an an Urgent Medical Device Correction letters dated April 11, 2012 and May 8, 2012 to all affected customers. The April notification advised of an anomaly with titanium rectal retractors, and the correction was expanded in May to include stainless steel retractors. In both notifications, users were instructed to discontinue use and quarantine their cleaned and sterilized devices for collection by Varian field service engineers. Users were requested to return an enclosed reply form to respond with number of units in inventory. |
| Quantity | 152 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011657 | HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR Mick Radio-Nuclear Instruments, Inc., Aug 27, 2001 |