Z-2668-2016Class II

TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge...

Name: Z-2668-2016 TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge...
Creator: Vision RT Ltd
Published: 2016-06-30
License: https://open.fda.gov/license/

Vision Rt Inc / initiated 2016-06-30 / Terminated

FDA source

Vision RT Ltd began a recall of TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic... on 2016-06-30. FDA classified it as Class II and gives the reason as "Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2668-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-30
Posted: 2016-08-25
Terminated: 2017-09-20
Recalling firm: Vision Rt Inc
Product: TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM 3194, No Serious Injury, No MDR, Aware date: Dec 11, 2015 2. CRM 3321, No Patient Involved, No MDR, Aware date: Jan 19, 2016 3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016 No patient harm was reported in any of these cases.
FDA root cause: Other
Action: Vision RT Ltd will provide all affected AlignRT Plus Users with an Urgent Medical Device Correction Notification letter, dated 2016-06-24 Subject: Unexpected Overwrite of Plan Couch Parameter. The letter will provide Users with a detailed description of the problem and provide instructions to avoid the issue. Non-responders will be notified again until we achieve 100% for North America and International consignees. Vision RT will make three (3) attempts using at least two different methods of contact to obtain proof of notification. Containment: Vision RT will provide a copy of the Urgent Medical Device Correction letter for any site accepting an AlignRT device. The letter will provide Users with a detailed description of the problem and provide instructions to avoid the issue. Product will not be returned to Vision RT. Varian Medical Systems and Vision RT are investigating development of a technical fix for the affected products. Notification of the intention to correct is provided in the Urgent Medical Device Correction Notification letter, dated 2016-06-24 Subject: Unexpected Overwrite of Plan Couch Parameter. Vision RT Ltd will contact all affected AlignRT Plus users and schedule upgrades to implement the correction when available.
Quantity in commerce: 47
Distribution: Product distributed in US. The foreign countries where the product was distributed are as follows: Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and United Kingdom. No product was distributed to US government accounts.
Product codes and lots: Serial Number of the device(s) distributed 248-016 248-021 248-022 248-030 248-038 248-041 248-063 248-064 249-1514 249-1516 248-071 249-0239 248-073 248-080 248-084 249-0043 249-0055 249-0056 249-0058 249-0069 249-0130 249-0137 249-1509 249-0141 249-0275 249-0152 249-0162 249-0169 249-0251 249-0253 249-0254 249-0288 249-1503 249-1512 249-1518 249-TBD 249-0061 249-0131 249-0256 249-0289 249-0290 249-TBD 248-083 249-0273 249-0276 249-1500 249-1519

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2668-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2667-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2668-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25

Product code IYE

K140528Class IITrue Beam, True Beam Stx, EdgeVarian Medical Systems, Inc. / cleared 2014-09-05

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)