RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1,…
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Read the official notice →- Date
- 2025-09-10
- Country
- United States
- Brand
- Raysearch Laboratories Ab
- Product
- RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1,…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Raysearch Laboratories Ab recalls
- 2026-07-08
USRAYSEARCH LABORATORIES AB recalls RayCare 2024A SP1. Oncology Information Systems.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
- 2026-01-28
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RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025,…
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…
FDA · DeviceRAYSEARCH LABORATORIES ABRefer to the attached documents: Distribution list 167168 US - updated,…Official notice → - 2025-02-26
- US
RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29,…
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT…
FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2024-05-08
- US
RAYSEARCH LABORATORIES AB recalls RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - 2024-04-17
- US
RAYSEARCH LABORATORIES AB recalls RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2023-11-08
- US
RAYSEARCH LABORATORIES AB recalls RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical…
An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with…
Other drugs & medical recalls in the United States
- 2025-09-10
- US
Visgeneer, Inc. recalls Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Due to products distributed without premarket clearance or approvals.
FDA · DeviceVisgeneer, Inc.Worldwide - U.S. Nationwide distribution in the states of CA and MI. The…Official notice → - US
Physio-Control, Inc. recalls LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is…
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FDA · DevicePhysio-Control, Inc.U.S. Nationwide distribution in the states of CO and MT.Official notice → - US
Medtronic MiniMed, Inc. recalls InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose…
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Reflexion Medical, Inc. recalls RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002…
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As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and…
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Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
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