RAYSEARCH LABORATORIES AB recalls TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6,…
If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware…
Read the official notice →- Date
- 2022-04-06
- Country
- United States
- Brand
- Raysearch Laboratories Ab
- Product
- TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19,…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AL, CA, FL, GA, IA, IL, MO, MS,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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- 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
- 2023-09-06
USRAYSEARCH 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 →- 2023-03-29
- US
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…
- 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…
- 2022-03-16
- US
RAYSEARCH LABORATORIES AB recalls RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2…
If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new…
Other drugs & medical recalls in the United States
- 2022-04-06
- US
Human Care USA, Inc. recalls Hanger-Bar 2P 45cm
The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). As a result of the set screw loosening, there is the potential…
FDA · DeviceHuman Care USA, Inc.U.S. Nationwide distribution in the states of CA, IL, LA, MA, NV, OH, OK, PA,…Official notice → - US
RaySearch America Inc recalls RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2…
Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.
FDA · DeviceRaySearch America IncUS Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, DE,…Official notice → - 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…
- US
Avanos Medical, Inc. recalls BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
Product was distributed with incorrect expiration date.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide distribution in the states of Oklahoma…Official notice → - US
Microbiologics Inc recalls Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria…
Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
FDA · DeviceMicrobiologics IncUS distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania,…Official notice → - US
Howmedica Osteonics Corp. recalls Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice →