Recall Z-0282-2012 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems, Inc.
Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segmented Cylinder Set, GM11004150)
| Date | Nov 23, 2011 (initiated May 20, 2010) |
| Status | Terminated |
| Reason | The Instructions For Use ( IFU) distributed with product prior to 2004 lacks the correct limit to the sterilization cycles and checks regarding the firm seating of the blocking washer. |
| Root cause | Labeling Change Control |
| Action | Varian Medical Systems sent a Medical Device Recall (PNL-GM-42697-2) in May 2010 for the blocking washer on the flexible probe, Varian part number GM11002420, a component of the Segmented Cylinder Applicator Set. The letter was to inform users that a flexible probe with an unstable or shifted blocking washer must not be used due to the potential for treatment length error. The blocking washer may move from rough handling or sterilization. Users were told to discard any instances of the obsolete Instructions for Use (IFU) in use and replace it with the IFU (PGM11004150 4 March 24, 2010.pdf). |
| Quantity | 81 parts |
| Distribution | Worldwide Distribution: USA, Germany, Belgium, Canada, Mexico City, Spain, Brazil, Switzerland, Uzbekistan, India |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033371 | VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS Varian Medical Systems, Dec 24, 2003 |