Recall Z-3098-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, version 8.1 SP2 to 10.0 SP1; Model Number: H51; Reference/PSCA Identifier: CP-03940; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: 4D Integrated treatment console is designed to assist the operator of a radiation device in providing accurate treatment set-ups for each pa
| Date | Aug 31, 2011 (initiated Jun 23, 2011) |
| Status | Terminated |
| Reason | Varian has scheduled for an upgrade of the device from current version to 10.2. There are circumstances in which the 4DITC may be involved in a failure to correctly record treatment history information. |
| Root cause | Software design |
| Action | Varian Medical Systems, Inc. sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated June 23, 2011 to all affected customers. The letter identified the product, problem and recommended user actions to follow. Customers were instructed to notify all appropriate personnel of the correction notice. The letter states that the recalling firm will issue a Customer Technical bulletin to inform users of the mandatory upgrade and related information. For future reference, this document will be posted to the Varian customer support website: http://www.MyVarian.com. Any qu |
| Distribution | Worldwide Distribution - USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081036 | 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) Varian Medical Systems, Inc., May 9, 2008 |