Class II U.S. Food and Drug Administration

Raysearch Laboratories Ab RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1 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

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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-1103-2026
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
10 units
Made in
Sweden
Lot / code info
Lot Code: UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916, 35000201063120220616. GTIN: 07350002010389, 07350002010433, 07350002010440, 07350002010631. Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116, 11.0.4.15. Software Revision: RayStation 11A, 11A SP1, 11A SP2, 11A SP3. Expiration Date: 2027-06-22.
UPC codes
07350002010389, 07350002010433, 07350002010440

Products covered by this recall

RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System

Check your product

The notice names 13 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.

  • 07350002010389
  • 07350002010433
  • 07350002010440

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • UDI

Best-by / use-by date

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

  • 2027-06-22. — 10 units

Model or item number

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

  • 11.0.0
  • 11.0.1
  • 11.0.3
  • 11.0.4. Software Version

Serial number

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

  • 11.0.0.951
  • 11.0.1.29
  • 11.0.3.116
  • 11.0.4

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  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.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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 07350002010389, 07350002010433, 07350002010440; lot code UDI; best-by date 2027-06-22. — 10 units; model number 11.0.0, 11.0.1, 11.0.3. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

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