RAYSEARCH LABORATORIES AB recalls Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0,…
It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not…
Read the official notice →- Date
- 2023-03-29
- Country
- United States
- Brand
- Raysearch Laboratories Ab
- Product
- Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0,…
- Classification
- Class II
- Units
- US Nationwide
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-04-17
USRAYSEARCH 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…
- 2023-09-06
- US
RAYSEARCH LABORATORIES AB recalls RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows…
An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances
FDA · DeviceRAYSEARCH LABORATORIES ABUS Nationwide distribution in the state of TN.Official notice → - 2022-07-27
- US
RAYSEARCH LABORATORIES AB recalls RayStation 9B SP1. For radiation treatment planning.
An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.
FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide distribution - US Nationwide distribution in the state of TN and the…Official notice → - 2022-07-06
- US
RAYSEARCH LABORATORIES AB recalls RayStation 11B
This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might…
FDA · DeviceRAYSEARCH LABORATORIES ABUS Nationwide distribution in the states of NJ and TX.Official notice → - 2022-04-06
- US
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13,…
An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be…
Other drugs & medical recalls in the United States
- 2023-03-29
- US
Biomet, Inc. recalls G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
- US
DeRoyal Industries Inc recalls DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum.
FDA · DeviceDeRoyal Industries IncUS Nationwide distribution in the states of Arizona, Texas, Virginia,…Official notice → - US
CooperVision, Inc. recalls Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
FDA · DeviceCooperVision, Inc.Worldwide - US Nationwide distribution in the states of FL, IL, NY, UT, and…Official notice → - US
Withings recalls Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen…
A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the device is only cleared for use under the care of a physician.
- US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to…
- US
Vapotherm recalls Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout.