Recall Z-1406-2010 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
PrecisePLAN 2.10 Treatment Planning System
| Date | Apr 16, 2010 (initiated Mar 15, 2006) |
| Status | Terminated |
| Reason | Error in dose rates which were calculated at exactly twice the expected values. |
| Root cause | Software design |
| Action | As described in a prior related submission, Phase I - "Important Notice A285, Scrolling Selected Frame Dose Calculator Error" dated March 15, 2006 was distributed to affected customers to inform them of the potential and what steps should be taken. Phase 2 -- Software release PrecisePLAN 2.11 was released July 11, 2006 to correct this problem. All customers with PrecisePLAN 2.10 will be upgraded to the revised software PrecisePLAN 2.11 through Field Change Order #772 00 540 052 dated June 5, 2006. Phase 3 -- All customers with PrecisePLAN 2.10 will be upgraded to the revised software Precis |
| Quantity | 40 units |
| Distribution | Worldwide: IL, NY, PA, TN, Canada, China, Czech Republic, Germany, India, Israel, Italy, Mexico, Poland, Russia, Spain, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022411 | PRECISEPLAN 2.0 Precision Therapy Intl., Inc., Sep 20, 2002 |