Recall Z-0891-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
4D Integrated Treatment Console, versions: 8.0.12, 8.0.23 SP2, 8.1 SP2, 8.1.1.3, 8.1.1.4, 8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2, 8.8.0; Model Number: H51; Distributed and manufactured by: Varian Medical Systems Inc., Palo Alto, CA Intended use: The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups
| Date | Jan 10, 2011 (initiated Oct 16, 2009) |
| Status | Terminated |
| Reason | Software anomaly may result in a design deficiency causing Plan Edit Settings to malfunction under specific circumstances, where the user selects to use a Cone Beam CT set up field. |
| Root cause | Device Design |
| Action | The firm, Varian Medical Systems, sent a Product Notification Letter/Field Safety Letter entitled "URGENT MEDICAL DEVICE CORRECTION" dated October 16, 2009, to all affected customers. The letter described the product, problem, actions to be taken by the customers and Varian. The customers were instructed to use caution when creating CBCT imaging field and limit use of the 'select all' button when acquiring treatment parameters; review departmental policies and procedures regarding the acquisition of any gantry angle at the 4D ITC, and advise the appropriate personnel of this letter. The |
| Quantity | 3629 |
| Distribution | Worldwide distribution: USA and countries including: Australia, Asia, China, Japan, Latin American, New Zealand , North America, South East Asia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091132 | 4D INTEGRATED TREATMENT CONSOLE Varian Medical Systems, Jun 17, 2009 |