Recall Z-0359-2012 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation Version 2.0.0.15 Consult instruction for use. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may b
| Date | Dec 2, 2011 (initiated Oct 19, 2011) |
| Status | Terminated |
| Reason | The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual. The symptoms involve the Pixel Spacing and Image Position attributes in the RT images being incorrect, thus enabling the user to make measurements that are erroneous and possibly misalign the patient. |
| Root cause | Device Design |
| Action | The firm, RaySearch Laboratories, sent an email with an "Urgent Field Safety Notice Medical Device Correction" notice dated October 19, 2011 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to pass on the information in the field safety notice to everyone involved and create routines to compensate for the incorrect DRR images; if the DICOM DRR images are not used to make any form of absolute measurements, no action needs to be taken. Raysearch laboratories will provide a script to update these DICOM files to have the correct va |
| Quantity | 19 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: MA, NJ, and NY; and country of: Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100552 | RAYSTATION VERSION 1.0 Raysearch Laboratories AB, Mar 12, 2010 |