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Terminated

PrecisePLAN 2.10 Treatment Planning System

FDA Recall Z-1406-2010 · Posted 2010-04-16

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2006-03-15
Date Terminated2010-12-30
Product Quantity40 units

Reason for Recall

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

Firm 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 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.

Root Cause

Software design

Distribution Pattern

Worldwide: IL, NY, PA, TN, Canada, China, Czech Republic, Germany, India, Israel, Italy, Mexico, Poland, Russia, Spain, Switzerland

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022411PRECISEPLAN 2.0Precision Therapy Intl., Inc. · 2002-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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