Z-1403-2022 Class II Terminated
FDA device recall Z-1403-2022 was initiated by RAYSEARCH LABORATORIES AB on Jun 1, 2022 and is designated Class II. 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. The recall status is terminated (terminated Oct 4, 2023). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 27, 2022
- Initiation Date
- Jun 1, 2022
- Termination Date
- Oct 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
RayStation 9B SP1. For radiation treatment planning.
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 Pattern
Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.
Code Information
UDI-DI: 0735000201029720200310 Build number 9.2.0.483
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1403-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026