RAYSEARCH LABORATORIES AB: Medical Device Recall in 2024 - (Recall #: Z-1747-2024)

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 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.

Product Classification:

Class II

Date Initiated: March 28, 2024

Date Posted: May 8, 2024

Recall Number: Z-1747-2024

Event ID: 94388

Reason for Recall:

Potential for reported SSD to be too high.

Status: Ongoing

Product Quantity: 18 units

Code Information:

UDI: 0735000201031020201216 and 0735000201047120220128; GTIN: 07350002010310 and 07350002010471; Serial Numbers: 10.1.0.613 and 10.1.1.54; Expiration Date: 2027-02-01.

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