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
Summary
The FDA issued a Class II for Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, by RAYSEARCH LABORATORIES AB. Reason: 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.
Details
Source
Device Recall
External ID
Z-1281-2023
Action Date
2023-03-29
Status
Ongoing
Category
device
Product Description
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, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packs
Lot/Code Info: UDI-DI: 0735000201067920221007;
Quantity Affected: 10770 systems
Reason for Recall
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 be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-17
Company
Stockholm, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 128 device recalls issued in the same week, part of 403 device-related FDA actions this month.
RAYSEARCH LABORATORIES AB has 51 FDA actions in our database, including 51 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (RAYSEARCH LABORATORIES AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RAYSEARCH LABORATORIES AB have FDA actions?
RAYSEARCH LABORATORIES AB has 51 FDA actions in our database, including 51 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1281-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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