FDA Device

PrecisePLAN 2.10 Treatment Planning System

Hazard

Error in dose rates which were calculated at exactly twice the expected values.

What You Should Do

Remedy

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.

Products

PrecisePLAN 2.10 Treatment Planning System
Brand
Elekta, Inc.
UPC
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

Units Affected

40 units