Vision RT Ltd Recall: TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delive
Vision RT Ltd Recall: TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delive is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Vision RT Ltd; Product: TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are i
| Recalling firm | Vision RT Ltd |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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. |
| Recall initiated | 20160630 |
| Recall number | Z-2668-2016 |
| Category | device |
| Country | United Kingdom |
$29/mo
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