Recall Z-1275-2018 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130
| Date | Jan 26, 2018 |
| Status | Terminated |
| Reason | Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient. |
| Root cause | Device Design |
| Action | On January 26, 2018 RaySearch Laboratories AB sent Field Safety Notice, Medical Device Correction #25955 to each customer via e-mail. Customers were advised of the following: be aware that Center Beam in Field affects all beams that share the same isocenter and that apertures may be modified in a way not intended; do not use Center Beam in Field after having created an opposed beam. If an opposed beam has been created, delete the opposed beam and use Center Beam in Field on the remaining beam. Then recreate the opposed beam; please educate planning staff and all users about this workaround; in |
| Quantity | 2484 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171536 | RayStation RaySearch Laboratories AB (PUBL), Jun 27, 2017 |