PrecisePLAN 2.10 Treatment Planning System
This recall has been terminated (originally issued April 16, 2010).
- Company
- Elekta, Inc.
- Recall Initiated
- March 15, 2006
- Posted
- April 16, 2010
- Terminated
- December 30, 2010
- Recall Number
- Z-1406-2010
- Quantity
- 40 units
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Error in dose rates which were calculated at exactly twice the expected values.
Distribution
Worldwide: IL, NY, PA, TN, Canada, China, Czech Republic, Germany, India, Israel, Italy, Mexico, Poland, Russia, Spain, Switzerland
Lot / Code Info
1762685762, 1762688017, 1762688506, 1726288507, 1762676911, 1762688175, 1762689384, 1762688019, 1762688022, 1762688876, 1762689442, 1762688177, 1762690813, 1762686657, 1762689588, 1762689386, 1762684357, 1762686833, 1762684370, 1762678238, 1762689519, 1762684359, 1762690814, 1762688514, 1762578223, 1762678239, 1762684360, 1762684361, 1762684362, 1762684367, 1762683737, 1762682414, 1762688081, 1762686584, 1762686843, 1762686832, 1762688024, 1762688080, 1762686836, 1762684358
Root Cause
Software design
Action Taken
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 PrecisePLAN 2.11 through Field Change Order #772 00 540 052 dated June 5, 2006. The company is directing questions to the local Electa representative or to their offices in the U.K. at telephone 44 (0)-1293-654200.