RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
Summary
The FDA issued a Class II for RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System. by RAYSEARCH LABORATORIES AB. Reason: Potential for reported SSD to be too high..
Details
Source
Device Recall
External ID
Z-1742-2024
Action Date
2024-05-08
Status
Ongoing
Category
device
Product Description
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
Lot/Code Info: UDI: 0735000201011220180608 and 0735000201013620180928; GTIN: 07350002010112 and 07350002010136; Serial Numbers: 8.0.0.61 and 8.0.1.10 Software Revisions: RayStation/RayPlan 8A and 8A Service Pack 1; Expiration Date: 2023-10-04.
Quantity Affected: 9 units
Reason for Recall
Potential for reported SSD to be too high.
Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-28
Company
Stockholm
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 175 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-1742-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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