Z-2668-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2016
- Initiation Date
- June 30, 2016
- Termination Date
- September 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47
Product Description
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.
Distribution Pattern
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.
Code Information
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