RAYSEARCH LABORATORIES AB: Medical Device Recall in 2021 - (Recall #: Z-1598-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs

Product Classification:

Class II

Date Initiated: April 7, 2021

Date Posted: May 26, 2021

Recall Number: Z-1598-2021

Event ID: 87868

Reason for Recall:

When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.

Status: Terminated

Product Quantity: N/A

Code Information:

Software version number: 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 , 10.1.0.613

Distribution Pattern:

Domestic: TN

Voluntary or Mandated:

Voluntary: Firm initiated