TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy… — Class II medical device recall Z-2668-2016
Terminated recall by Vision RT Ltd, reported 2016-08-31. Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended
| Recall number | Z-2668-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vision RT Ltd, London, United Kingdom |
| Recall initiated | 2016-06-30 |
| Classified | 2016-08-25 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2017-09-20 |
| Countries outside the US | CA, CH, DE, GB, JP, SE, TW |
| Quantity | 47 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2668-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.