RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStatio
Summary
The FDA issued a Class II for RayStation with the following product descriptions: 1. RayStation 11A, Softw by RAYSEARCH LABORATORIES AB. Reason: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique..
Details
Source
Device Recall
External ID
Z-2491-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3, Software Version: 11.0.4.15. Product Description: Radiation Therapy Treatment Planning System.
Lot/Code Info: 1. Software Version: 11.0.0.951, UDI: 0735000201038920210518. 2. Software Version: 11.0.1.29, UDI: 0735000201043320210610. 3. Software Version: 11.0.3.116, UDI: 0735000201044020210916. 4. Software Version: 11.0.4.15, UDI: 0735000201063120220616. Expiration Date: 2027-06-22
Quantity Affected: 3
Reason for Recall
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Distribution
Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-08
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 258 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-2491-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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