Recall Z-0079-2017 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
Radiation Therapy Treatment Planning System, Model 5.0
| Date | May 30, 2016 |
| Status | Terminated |
| Reason | For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics. |
| Root cause | Software design |
| Action | On May 19th, 2016, RaySearch Laboratories distributed Field Safety Notice, Medical Device Correction notices and reply forms to their customers via email. Actions to be taken by the customer include: 1) Inspect all report templates that are intended to be used for plans with multiple beam sets. 2) Make sure that POI Dose statistics (Plan) is included immediately before ROI Dose statistics [Plan dose] in the Report content area. 3) Please educate planning staff and all users about this workaround. 4) Inspect your product and identify all installed units with the above software version number |
| Quantity | 491 units (187 domestically & 304 internationally) |
| Distribution | AZ, CA, FL, MT, NC NY, TX, OH & WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160093 | RayStation RaySearch Laboratories AB (PUBL), Apr 8, 2016 |