Z-0934-2015Class II

AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin...

Name: Z-0934-2015 AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin...
Creator: Vision Rt Inc
Published: 2014-11-11
License: https://open.fda.gov/license/

Vision Rt Inc / initiated 2014-11-11 / Terminated / root cause: software

FDA source

Vision Rt Inc began a recall of AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during... on 2014-11-11. FDA classified it as Class II and gives the reason as "Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened". 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-0934-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-11
Posted: 2015-01-07
Terminated: 2016-05-11
Recalling firm: Vision Rt Inc
Product: AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: VisionRT sent an Urgent Medical Device Correction Notification letter dated November 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers shall: A. Print the instructions in Appendix 3, place them in the front of the product guide and ensure these instructions are read and understood by all those who need to be aware of them within their organisation; B. Maintain awareness of this issue until all actions indicated in this letter have been successfully completed; C. Promptly inform Vision RT if they believe that patient harm occurred due to this issue; AND D. Complete the acknowledgement in Appendix 1 and return it via email to [email protected]. Contact Vision RT 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. For questions regarding this recall call 866-594-5443.
Quantity in commerce: 55
Distribution: Nationwide Distribution
Product codes and lots: Serial numbers (internally referred to as PCR numbers): USA: 247-018, 247-039, 247-040, 247-053, 247-060, 247-061 , 247-062, 247-063, 247-068, 247-071 , 247-075, 247-076 , 247-078, 247-081, 247-083, 247-096, 247-099, 247-100,, 247-101, 247-102 , 247-110 , 247-118, 247-119, 247-122, 247-124, 247-127, 247-129, 247-130, 247-138, 247-140, 247-142, 247-149, 247-150, 247-153, 247-161, 247-167, 247-171, 247-184, 247-194, 247-200, 247-207, 247-212, 247-213, 248-012, 248-018, 248-041 Rest of the world: 247-035, 247-073, 247-114, 247-131, 247-147, 247-148, 247-188

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0934-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0934-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-07

Product code IYE

K052682Class IIAlignrtVision RT Limited / cleared 2006-01-06

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)