Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1. For the treatment planning and image guided radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
This recall has been terminated (originally issued February 2, 2011).
- Company
- Accuray Inc
- Recall Initiated
- January 15, 2010
- Posted
- February 2, 2011
- Terminated
- February 11, 2011
- Recall Number
- Z-1023-2011
- Quantity
- 99 units
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
When a user modified the align center of an existing plan during the treatment planning process the effective depths of each beam in the plan were not updated by the system. These depths were incorrect and led to an incorrect dose calculation. Software patch /update to address this issue. Implementation at affected sites will initiate, once the patch is available.
Distribution
Worldwide Distribution: USA and countries including: Canada, Turkey, India, Russia, Italy, France, Belgium, Netherlands the UK, Spain, Athens, Saudi Arabia, Switzerland, the Ukraine, Germany, Korea and Hong Kong.
Lot / Code Info
Item Number : 025000. Serial Number: C0150. Model numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.50, and 3.5.1.
Root Cause
Software design
Action Taken
The firm, Accuray, sent an "URGENT DEVICE CORRECTION" letter dated January 18, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to load the plan and recalculate the dose to reflect the current state of beam, compare the reloaded plan and the recalculated plan to verify maximum dose and prescription values, and re-prescribe and save to overwrite to existing plan if necessary. The firm is developing a patch/software update to address the issue and a Accuray Customer Support person will contact the customer regarding further resolutions. If you have any questions or concerns regarding this issue, contact Accuray Customer Support at +1-877-668-8667(USA) or +1-408-716-4700 (non USA) or email: customersupport@accuray.com.