Recall Z-2119-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup p
| Date | Apr 29, 2011 (initiated Feb 28, 2011) |
| Status | Terminated |
| Reason | A software anomaly, in that the Multileaf Collimator (MLC) message displayed on the 4DITC on versions 8.6 and below, does NOT interlock beam delivery. |
| Root cause | Software design |
| Action | Varian Medical Systems sent an Urgent Medical Device Correction Letter on February 28, 2011, to all affected customers. Varian has created the procedure described in CTB-GE-579 to inform users on proper interfacing of the demountable BrainLAB m3 on the Varian Clinac. The procedure ( CTB-GE-579) is enclosed and posted to the customer site: http://www.MyVarian.com. This design fix in 4DITC v10.1 or later will be provided to all affected sites. If you require further clarification, please feel free to contact your local Varian Customer Support District or Regional Manager. USA and Canada - |
| Quantity | 17 |
| Distribution | Class 2 Recall - Worldwide Distribution -- USA including states of ; CA, NV, NJ, GA, IL, and TX and countries of Australasia, Belgium, Brazil, China P.R., Denmark, France, Germany, Germany ( BrachyTherapy) Hong Kong, India Pvt. Ltd, Italy, Japan, Middle East, Netherlands, Russia, Spain, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091132 | 4D INTEGRATED TREATMENT CONSOLE Varian Medical Systems, Jun 17, 2009 |