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RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15.… recallZ-1748-2024 · Raysearch Laboratories AB · initiated Mar 28, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Raysearch Laboratories AB or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for reported SSD to be too high.

FDA root cause category: Software design

What the company is doing

A Field Safety Notice for Medical Device Correction #133261, dated 3/28/24, was sent to consignees via email. Consignees were provided the instructions to use the Measure Tool to measure the distance in the patient view to make sure the reported SSD value is correct if it is to be used for patient setup or other critical tasks. If the SSD value is found to be incorrect, small changes to the isocenter, beam angles or the affected ROI's geometry can be made until the correct value is achieved. Consignees are to inform planning staff and all users of the workarounds provided in the Field Safety Notice. Consignees are to inspect their product and identify if installed units possess the affected software versions. Consignees are to reply to the recall notification confirming that they read and understood the Field Safety Notificaiton. RaySearch is to deploy a new version of RayStation/RayPlan to correct the issue, to be released in April 2024. The provided Field Safety Notice is to be maintained with affected units. Consignees with any questions are to contact [email protected].

Recall details

Recall number
Z-1748-2024
Status
Open, Classified
Initiated by the company
Mar 28, 2024
Posted by the FDA
May 1, 2024
Recalling firm
Raysearch Laboratories AB
Quantity
10 units
Product code
MUJ
FDA submissions
K211867
Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

Product description

RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.

Code information (models, lots, serial numbers)

UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916 and 0735000201063120220616; GTIN: 07350002010389, 07350002010433, 07350002010440 and 07350002010631; Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15; Expiration Date: 2027-06-22.

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 94388).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page