Recall Z-3100-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc Treatment Plan as a 3D Conformal Arc Treatment Plan; version v8.6 or 8.8 in combination with treatment planning systems; Model Number: H51; Reference/PSCA Identifier: CP-03063; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: 4D Integrated tre
| Date | Aug 30, 2011 (initiated Jun 27, 2011) |
| Status | Terminated |
| Reason | In certain configurations, the 4DITC can interpret a RapidArc or VMAT treatment field as 3D Conformal Arc Treatment Plan. If a RapidArc or VMAT treatment field is incorrectly interpreted as Conformal Arc, the field will be delivered with a constant dose rate and gantry speed for the entire duration of the delivery, which can lead to delivered dose being different than planned. |
| Root cause | Software design |
| Action | Varian sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated June 27, 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 Varian Service will contact customers to arrange to perform update to 4D Integrated Treatment Console (4DITC) software. For further clarification, contact your local Varian Customer Support District or Regional Manager. The letter also provides Varian Oncology Help desk |
| Quantity | 645 |
| 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 |