TomoHelical and TomoDirect plans in RayStation 6, 7, 8A… recallZ-0848-2022 · Raysearch Laboratories AB · initiated Sep 9, 2021

Why it was recalled

If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning

FDA root cause category: Under Investigation by firm

What the company is doing

RaySearch issued Field Safety Notice, Medical Device Correction #83773 notice via email on Sept. 9, 2021. Letter states reason for recall, health risk and action to take: ACTIONS TO BE TAKEN BY THE USER " Avoid changing the dose grid after starting an optimization of TomoHelical and TomoDirect plans with dynamic jaw mode. " Always reset the optimization after editing the dose grid for TomoHelical and TomoDirect plans with dynamic jaw mode. " Always reset the optimization after modifying the target ROI. " It is recommended to use the BEV to inspect the jaw positions superior and inferior to the target dynamic jaw mode. " Educate planning staff and all users about this workaround. " Inspect your product and identify all installed units with the above software version number(s). " Confirm you have read and understood this notice by replying to the notification email. SOLUTION This issue will be resolved in the next version of RayStation, scheduled for market release in October 2021 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use. For regulatory information, please contact [email protected].

Recall details

Recall number

Z-0848-2022

Status

Terminated

Initiated by the company

Sep 9, 2021

Recalling firm

Raysearch Laboratories AB

Quantity

51 (US) Licenses

Product code

MUJ

FDA submissions

K210645

Distribution

US Nationwide distribution in the states of AL, CA, FL, GA, IA, IL, MO, MS, NC, OK, OR, SC, TN, WA, WI.

Product description

TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29.

Devices named in this recall

16 devices in the FDA device registry whose identifier appears in the recall's code information.

• RayStation 9

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  12 recalls0 reports
• RayStation 8.0.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  11 recalls0 reports
• RayStation 9B SP1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  11 recalls0 reports
• RayStation 10.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  10 recalls1 report
• RayStation 8.0

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  10 recalls0 reports
• RayStation 8.1.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  9 recalls0 reports
• RayStation 10.0

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  9 recalls0 reports
• RayStation 10.0.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  9 recalls0 reports
• RayStation 7

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  8 recalls0 reports
• RayStation 8.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  8 recalls0 reports
• RayStation 8.1.2

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  8 recalls0 reports
• RayStation 11.0

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  8 recalls0 reports
• RayStation 6.2

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  7 recalls0 reports
• RayStation 6.1.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  7 recalls0 reports
• RayStation 11.0.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  7 recalls0 reports
• RayStation 6.1

  Raysearch Laboratories AB (Publ) · System,Planning,Radiation Therapy Treatment
  2 recalls0 reports