Z-1748-2024 Class II Ongoing
FDA device recall Z-1748-2024 was initiated by RAYSEARCH LABORATORIES AB on Mar 28, 2024 and is designated Class II. Reason for recall: Potential for reported SSD to be too high. The recall status is ongoing. Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2024
- Initiation Date
- Mar 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
Reason for Recall
Potential for reported SSD to be too high.
Distribution Pattern
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.
Code Information
UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916 and 0735000201063120220616; GTIN: 07350002010389, 07350002010433, 07350002010440 and 07350002010631; Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15; Expiration Date: 2027-06-22.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1748-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026