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
This recall has been terminated (originally issued January 26, 2018).
- Recall Initiated
- January 26, 2018
- Terminated
- January 13, 2020
- Recall Number
- Z-1275-2018
- Quantity
- 2484
- Official Source
- View on FDA website ↗
Reason for Recall
Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
Distribution
Nationwide
Lot / Code Info
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
Root Cause
Device Design
Action Taken
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; inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this notice by replying to the notification via email, fax or by calling local support. Customers with questions were instructed to contact David Hedfors via e-mail at david.hedfors@raysearchlabs.com