Summary
The FDA issued a Class II for RayStation 9B SP1. For radiation treatment planning. by RAYSEARCH LABORATORIES AB. Reason: An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, informa.
Details
Source
Device Recall
External ID
Z-1403-2022
Action Date
2022-07-27
Status
Terminated
Category
device
Product Description
RayStation 9B SP1. For radiation treatment planning.
Lot/Code Info: UDI-DI: 0735000201029720200310 Build number 9.2.0.483
Quantity Affected: 1
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-01
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 176 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-1403-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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