Recall Z-1175-2012 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; Varian Medical Systems, Palo, Alto, CA 94304. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
| Date | Mar 6, 2012 (initiated Jan 30, 2012) |
| Status | Terminated |
| Reason | An anomaly has been identified with the respiratory gating software of TrueBeam. When importing breath-hold gating protocols, the gating thresholds can be reset to default values, rather than retaining the thresholds established during planning. |
| Root cause | Device Design |
| Action | Urgent Medical Device Correction/Urgent Field Safety Notices were sent on January 30, 2012 by certified mail to US and Canadian consignees. ***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.*** Varian Sales, Marketing and Service Organizations also were informed via letter the same day. The Field Safety Notice with customer distribution list was e-mailed to Varian International Customer Support Managers for translation (if necessary) to be sent to affected sites with return proof of notification t |
| Quantity | 182 units ***12-12-12 AMENDED TO: 200 units*** |
| Distribution | Nationwide Distribution (USA) and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Netherlands, New Zealand, Norway, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, Turkey and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111106 | TRUEBEAM Varian Medical Systems, Inc., Aug 18, 2011 |