Recall Z-1001-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Varian brand C Series Clinics (Includes Trilogy, and Novalis Tx), Model Numbers: H14, H26, H27, H29, Distributed by and/or Manufactured by: Varian Medical Systems Inc., Palo Alto, CA The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside
| Date | Jan 31, 2011 (initiated Dec 1, 2009) |
| Status | Terminated |
| Reason | A circuit design anomaly whereby a faulty balance potentiometer can lead to an undetected electron beam asymmetry. |
| Root cause | Device Design |
| Action | The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 1, 2009 via Federal Express to consignees/customers. The letter described the product, problem and actions to be taken by the customers and the firm. The customers were instructed to perform a verification of field symmetry on electron beam energies to determine the threshold and report any field symmetry issues to their local Varian service office for attention. The firm, Varian, is developing new functionality to detect the symptoms of this component failure condition under all conditions of e |
| Quantity | 4411 |
| Distribution | USA and countries including: Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Belorussia, Bolivia, Brazil, Canada, Chile,, China, Columbia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France,French Polynesia, Germany, Guadeloupe, Guatemala, |
| FDA record | Open on fda.gov |