RAYSEARCH LABORATORIES AB: Medical Device Recall in 2020 - (Recall #: Z-2426-2020)

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 standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2

Product Classification:

Class II

Date Initiated: May 26, 2020

Date Posted: July 1, 2020

Recall Number: Z-2426-2020

Event ID: 85796

Reason for Recall:

It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.

Status: Ongoing

Product Quantity: 12

Code Information:

Software versions 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 and 9.2.0.483

Distribution Pattern:

Distributed to one consignee in Nashville. Foreign distribution to one consignee in Belgium.

Voluntary or Mandated:

Voluntary: Firm initiated