Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi

FDA device recall Z-1023-2011 · posted 2011-02-02 · Terminated

Recall details

Recalling firm

Accuray Inc

Reason for recall

When a user modified the align center of an existing plan during the treatment planning process the effective depths of each beam in the plan were not updated by the system. These depths were incorrect and led to an incorrect dose calculation. Software patch /update to address this issue. Implementation at affected sites will initiate, once the patch is available.

Action taken

The firm, Accuray, sent an "URGENT DEVICE CORRECTION" letter dated January 18, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to load the plan and recalculate the dose to reflect the current state of beam, compare the reloaded plan and the recalculated plan to verify maximum dose and prescription values, and re-prescribe and save to overwrite to existing plan if necessary. The firm is developing a patch/software update to address the issue and a Accuray Customer Support person will contact the customer regarding further resolutions. If you have any questions or concerns regarding this issue, contact Accuray Customer Support at +1-877-668-8667(USA) or +1-408-716-4700 (non USA) or email: customersupport@accuray.com.

Root cause

Software design

Status

Terminated

Product code

MUJ

Quantity affected

99 units

Distribution

Worldwide Distribution: USA and countries including: Canada, Turkey, India, Russia, Italy, France, Belgium, Netherlands the UK, Spain, Athens, Saudi Arabia, Switzerland, the Ukraine, Germany, Korea an

Date initiated

2010-01-15

Date posted

2011-02-02

Date terminated

2011-02-11

Location

Sunnyvale, CA

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