RAYSEARCH LABORATORIES AB: Medical Device Recall in 2020 - (Recall #: Z-2339-2020)

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 4.0 to RayStation 5 Service Pack 2 - 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-2339-2020

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:

Build numbers: 4.0.3.4, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 5.0.1.11, 5.0.2.35,

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