Class II U.S. Food and Drug Administration

Raysearch Laboratories Ab RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0 recall: Potential for the invalidation for calculated radiation dose does not work

Recall published 9 months ago

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1104-2026
Published
January 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Raysearch Laboratories Ab
Product type
Medical devices
Units affected
22 units
Made in
Sweden
Lot / code info
UDI: 0735000201042620211208, 0735000201049520220312, 0735000201050120220422, 0735000201060020220620 and 0735000201057020221222. GTIN: 07350002010426, 07350002010495, 07350002010501, 07350002010600 and 07350002010570. Serial Numbers: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12, 12.3.0.119. Software Revisions: RayStation 11B, 11B SP1, 11B SP2, 11B SP3, 11B SPT1. Expiration Date: 2028-03-20.
UPC codes
07350002010426, 07350002010495, 07350002010501, 07350002010600

Products covered by this recall

RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System

Check your product

The notice names 14 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 07350002010426
  • 07350002010495
  • 07350002010501
  • 07350002010600

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2028-03-20. — 22 units

Model or item number

On the rating label, the box or the instruction sheet.

  • 12.0.0
  • 12.1.0
  • 12.0.3
  • 12.0.4
  • 12.3.0. Software Ve

Serial number

On the rating plate, often next to the date of manufacture.

  • 12.0.0.932
  • 12.1.0.1221
  • 12.0.3.68
  • 12.0

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Raysearch Laboratories Ab — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: RAYSEARCH LABORATORIES AB — Eugeniavagen 18c, Stockholm

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Raysearch Laboratories Ab medical devices recalled?

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended. Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 07350002010426, 07350002010495, 07350002010501; best-by date 2028-03-20. — 22 units; model number 12.0.0, 12.1.0, 12.0.3. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

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