RAYSEARCH LABORATORIES AB: Medical Device Recall in 2018 - (Recall #: Z-1275-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130

Product Classification:

Class II

Date Initiated: January 26, 2018

Date Posted: April 4, 2018

Recall Number: Z-1275-2018

Event ID: 79582

Reason for Recall:

Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.

Status: Terminated

Product Quantity: 2484

Code Information:

Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated