Z-1023-2011

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

Name: Z-1023-2011 Radiation therapy device. Medical charged particle radiation therapy system with software version. Model...
Creator: Accuray Inc
Published: 2010-01-15
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2010-01-15 / Terminated / root cause: software

FDA source

Accuray Inc began a recall of Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System... on 2010-01-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1023-2011
Status: Terminated
Initiated: 2010-01-15
Posted: 2011-02-02
Terminated: 2011-02-11
Recalling firm: Accuray Incorporated
Product: Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1. For the treatment planning and image guided radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Product code: MUJ System, Planning, Radiation Therapy Treatment
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.
Root cause tag: software
FDA root cause: Software design
Action: 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: [email protected].
Quantity in commerce: 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 and Hong Kong.
Product codes and lots: Item Number : 025000. Serial Number: C0150. Model numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.50, and 3.5.1.

Product code MUJ

K091146Class IIModification to Cyberknife Robotic Radiosurgery SystemAccuray, Inc. / cleared 2009-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)