CLASS II ONGOING Device recall · Reported 28 Jan 2026 · FDA Enforcement Report

RayStation/RayPlan recalled by Raysearch Laboratories Ab

Raysearch Laboratories AB is recalling RayStation/RayPlan. The recall was initiated on 28 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: UDI: 0735000201054920220616, 0735000201067920221007, 0735000201073020230913 GTIN: 07350002010549, 07350002010679, 07350002010730 Serial Numbers: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Revisions: RayStation 12A, 12A SP 1, 12A SP2 Expiration Date: 2028-07-07

Quantity recalled8

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1105-2026
FDA event ID: 98117
Recalling firm: Raysearch Laboratories AB, Stockholm
Classification: Class II
Status: Ongoing
Recall initiated: 28 Nov 2025
FDA classified: 16 Jan 2026
Reported: 28 Jan 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Medical Software

Timeline

28 Nov 2025	Recall initiated by company
16 Jan 2026	Classified by FDA	+49 days
28 Jan 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No

Where it was distributed

Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Code: UDI: 0735000201054920220616, 0735000201067920221007, 0735000201073020230913 GTIN: 07350002010549, 07350002010679, 07350002010730 Serial Numbers: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Revisions: RayStation 12A, 12A SP 1, 12A SP2 Expiration Date: 2028-07-07

Where was it sold?

Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 98117

This product is part of a recall event; the main page for the event is RayStation/RayPlan recalled by Raysearch Laboratories Ab.

Reported	Class	Recall	Company	Reason
28 Jan 2026	CLASS II	RayStation/RayPlan recalled by Raysearch Laboratories Ab	Raysearch Laboratories AB	Device Malfunction
28 Jan 2026	CLASS II	RayStation/RayPlan recalled by Raysearch Laboratories Ab	Raysearch Laboratories AB	Device Malfunction
28 Jan 2026	CLASS II	RayStation/RayPlan recalled by Raysearch Laboratories Ab	Raysearch Laboratories AB	Device Malfunction
28 Jan 2026	CLASS II	RayStation/RayPlan recalled by Raysearch Laboratories Ab	Raysearch Laboratories AB	Device Malfunction
28 Jan 2026	CLASS II	RayStation/RayPlan recalled by Raysearch Laboratories Ab	Raysearch Laboratories AB	Device Malfunction
28 Jan 2026	CLASS II	RayStation/RayPlan recalled by Raysearch Laboratories Ab	Raysearch Laboratories AB	Device Malfunction
28 Jan 2026	CLASS II	RayStation/RayPlan recalled by Raysearch Laboratories Ab	Raysearch Laboratories AB	Device Malfunction
28 Jan 2026	CLASS II	RayStation/RayPlan recalled by Raysearch Laboratories Ab	Raysearch Laboratories AB	Device Malfunction

More recalls from Raysearch Laboratories AB

All 115

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	RayCare 2024A SP4 recalled by Raysearch Laboratories Ab	Raysearch Laboratories AB	Other	Nationwide
8 Jul 2026Device	CLASS II	RayCare 2024A SP1 recalled by Raysearch Laboratories Ab	Raysearch Laboratories AB	Other	Nationwide
28 Jan 2026Device	CLASS II	RayStation/RayPlan recalled by Raysearch Laboratories Ab	Raysearch Laboratories AB	Device Malfunction
28 Jan 2026Device	CLASS II	RayStation/RayPlan recalled by Raysearch Laboratories Ab	Raysearch Laboratories AB	Device Malfunction
28 Jan 2026Device	CLASS II	RayStation/RayPlan recalled by Raysearch Laboratories Ab	Raysearch Laboratories AB	Device Malfunction

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