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Brand Name: RayStation recallZ-1107-2026 · Raysearch Laboratories AB · initiated Nov 28, 2025

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 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.

FDA root cause category: Under Investigation by firm

What the company is doing

RaySearch Laboratories notified consignees via email on about 12/05/2025. Consignees were instructed to follow the outlined steps in the notification letter when adding geometry to an empty ROI with MO or type Bolus, Fixation or Support, educate planning staff and all users about the workaround, inspect units and identify all installed units with the affected software version numbers, and confirm receipt and understanding of the customer notification by responding to the notification email. The issue will be resolved in the next version of RayStation, scheduled for market release in December 2025 (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. The upgrade to an unaffected software version will be scheduled in coordination with the authorized personnel, considering the specific circumstances and requirements of each individual case. The upgrade may be conducted remotely or onsite, as deemed appropriate.

Recall details

Recall number
Z-1107-2026
Status
Open, Classified
Initiated by the company
Nov 28, 2025
Posted by the FDA
Jan 16, 2026
Recalling firm
Raysearch Laboratories AB
Quantity
0
Product code
MUJ
Distribution
Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS

Product description

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No

Code information (models, lots, serial numbers)

Lot Code: UDI: 0735000201047120220131 GTIN: 07350002010471 Serial Numbers: 10.1.1.54 Software Revision: RayStation 10B SP1 Expiration Date: 2027-02-01

Devices named in this recall

1 device 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 98117).

Sources and updates

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