RaySearch America Inc: Medical Device Recall in 2023 - (Recall #: Z-2039-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.

Product Classification:

Class II

Date Initiated: January 22, 2021

Date Posted: July 5, 2023

Recall Number: Z-2039-2023

Event ID: 92441

Reason for Recall:

A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.

Status: Terminated

Product Quantity: 5 systems

Code Information:

UDI-DI: 07350002010129 UDI-DI: 07350002010204 UDI-DI: 07350002010235 UDI-DI: 07350002010174 UDI-DI: 07350002010266 UDI-DI: 07350002010297 UDI-DI: 07350002010303 UDI-DI: 07350002010365 UDI-DI: 07350002010310

Distribution Pattern:

US: AZ, CA, GA & WA

Voluntary or Mandated:

Voluntary: Firm initiated