Z-0464-2015Class II

AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and...

Name: Z-0464-2015 AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and...
Creator: Vision Rt Inc
Published: 2014-10-15
License: https://open.fda.gov/license/

Vision Rt Inc / initiated 2014-10-15 / Terminated / root cause: software

FDA source

Vision Rt Inc began a recall of AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for... on 2014-10-15. FDA classified it as Class II and gives the reason as "Potential failure of AlignRT to assert interlock". 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-0464-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-15
Posted: 2014-12-16
Terminated: 2016-05-10
Recalling firm: Vision Rt Inc
Product: AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Potential failure of AlignRT to assert interlock.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: The firm, visionrt. sent an "URGENT MEDICAL DEVICE CORRECTION NOTIFICATION-URGENT FIELD SAFETY NOTICE" dated October 15, 2014 to all affected customers on 21-Oct-2014. The notice describes the product, problem and actions to be taken. The customers were informed that they did not need to return their devices; they should pass the letter to all those who need to be aware of it within their organization; promptly inform Vision RT if they believe that patient harm occurred due this issue, and complete and return the acknowledgement form via email to [email protected]. Vision RT is designing an upgrade that will resolve the issue, and will subsequently contact the customer in order to install the upgrade on their device. Should you have any queries on this letter, please do not hesitate to contact Vision RT by telephone on +44 20 83464300 (866 778-2379 from the US) or as per http://www.visionrt.com/contact/details.
Quantity in commerce: 7 (Six Units distribited in the US and One in OUS.)
Distribution: Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.
Product codes and lots: Affected software version: Software versions 5.0.1738 and 5.0.1742 only. Affected serial numbers: 248-052, 248-066, 248-088, 249-0059, 249-0133, 249-0134, 249-0139.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0464-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0464-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25

Product code IYE

K123371Class IIAlignrt PlusVision RT Limited / cleared 2013-01-08

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)