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Terminated

PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments.

FDA Recall Z-1476-2011 · Posted 2011-03-02

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2008-01-28
Date Terminated2011-04-21
Product Quantity277 units

Reason for Recall

PrecisePLAN generates digitally Reconstructed Radiographs (DRR;s) with a shift in the superior direction.

Firm Action

Elekta sent an Important Notice A308 letter dated January 28, 2008, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Elekta representative directly if they had any questions. .

Root Cause

Other

Distribution Pattern

Worldwide Distribution - USA and the countries of Bulgaria, Switzerland, Czech Republic, Germany, Spain, France, Hungary, Ireland, Italy, Liechtenstein, Netherlands, Poland, Portugal, Sweden, Slovak Republic, Australia, China, Hong Kong, and Japan,

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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