RayStation Software Version Numbers version numbers 8B, 9A… recallZ-1482-2024 · Raysearch Laboratories AB · initiated Feb 23, 2024

Why it was recalled

A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.

FDA root cause category: Under Investigation by firm

What the company is doing

On February 26, 2024, the firm notified customers of the issue via Urgent Field Safety Notice: Medical Device Correction letters via email. Actions to be taken by the user: 1. Educate planning staff and all users about the possibility of the described use error. 2. If the use error is deemed likely to occur at your clinic, take actions to ensure that proper review of assigned materials is performed before a patient model is used for treatment planning. 3. If you wish to have the Silicon chemical element removed from the material list, contact RaySearch support for assistance. This is especially recommended for clinics that perform ion beam treatments, where the harm caused by the use error could be significant. 4. Inspect your product and identify all installed units with the above software version number(s). 5. Confirm you have read and understood this notice by replying to the notification email. The Silicon chemical element will not be included in the next version of RayStation/RayPlan, scheduled for market release in April 2024 (subject to market clearance in some markets). If requested by the customer, it can be removed from the material list of existing installations. This notice needs to be passed on to all those who need to be aware within your organization. Maintain awareness of this notice as long as any affected version is in use. Thank you for your cooperation, and we apologize for any inconvenience. For regulatory information, please contact [email protected].

Recall details

Recall number

Z-1482-2024

Status

Open, Classified

Initiated by the company

Feb 23, 2024

Posted by the FDA

Apr 5, 2024

Recalling firm

Raysearch Laboratories AB

Quantity

154 units

Product code

MUJ

FDA submissions

K190387, K200569, K210645, K211867, K220141, K222312

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hong Kong S.A.R., Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, P.R. China, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom.

Product description

RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.

Devices named in this recall

20 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 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 8.1.1

  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 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 11.0.1

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

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  5 recalls0 reports
• RayStation 11A SP2

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  5 recalls0 reports
• RayStation 10B SP1

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

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  4 recalls0 reports
• RayStation 11B SP2

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

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  4 recalls0 reports
• RayStation 2023B

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  4 recalls0 reports
• RayStation 11B SPT1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  4 recalls0 reports
• RayStation 12A SP1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  4 recalls0 reports
• RayStation 12A SP2

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