RAYSEARCH LABORATORIES AB: Medical Device Recall in 2024 - (Recall #: Z-1742-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.

Product Classification:

Class II

Date Initiated: March 28, 2024

Date Posted: May 8, 2024

Recall Number: Z-1742-2024

Event ID: 94388

Reason for Recall:

Potential for reported SSD to be too high.

Status: Ongoing

Product Quantity: 9 units

Code Information:

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated