RAYSEARCH LABORATORIES AB: Medical Device Recall in 2020 - (Recall #: Z-2348-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

Product Classification:

Class II

Date Initiated: May 18, 2020

Date Posted: June 17, 2020

Recall Number: Z-2348-2020

Event ID: 85723

Reason for Recall:

Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.

Status: Terminated

Product Quantity: N/A

Code Information:

UDI # 07350002010235 Build number: 8.1.2.5

Distribution Pattern:

US Nationwide distribution including in the states of Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.

Voluntary or Mandated:

Voluntary: Firm initiated