Recall Z-1495-2012 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
True Beam; Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below. Varian Medical Systems, Palo Alto, CA. Product Usage: TrueBeam Radiotherapy delivery system is intended to provide sterotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
| Date | May 8, 2012 (initiated Apr 9, 2012) |
| Status | Terminated |
| Reason | A software anomaly has been identified in TrueBeam when using respiratory gating with patients in the prone position. The gating curve is inverted when a prone patient plan is loaded into TrueBeam. |
| Root cause | Device Design |
| Action | Varian sent an Urgent Medical Device Correction - Urgent Field Safety Notice dated April 13, 2012 to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the affected product, description of problem, details and recommended user actions. Varian will provide a software version that will mitigate the issue described in the letter and Varian Customer Support will notify each affected facility when the software is available. The letter instructs custo |
| Quantity | 207 devices ***12-12-12 AMENDED TO: 216 UNITS*** |
| Distribution | Worldwide Distribution - USA Nationwide and the countries ofAustralia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111106 | TRUEBEAM Varian Medical Systems, Inc., Aug 18, 2011 |