RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.

FDA device recall Z-1750-2024 · posted 2024-05-01 · Open, Classified

Recall details

Recalling firm

RAYSEARCH LABORATORIES AB

Reason for recall

Potential for reported SSD to be too high.

Action taken

A Field Safety Notice for Medical Device Correction #133261, dated 3/28/24, was sent to consignees via email. Consignees were provided the instructions to use the Measure Tool to measure the distance in the patient view to make sure the reported SSD value is correct if it is to be used for patient setup or other critical tasks. If the SSD value is found to be incorrect, small changes to the isocenter, beam angles or the affected ROI's geometry can be made until the correct value is achieved. Consignees are to inform planning staff and all users of the workarounds provided in the Field Safety Notice. Consignees are to inspect their product and identify if installed units possess the affected software versions. Consignees are to reply to the recall notification confirming that they read and understood the Field Safety Notificaiton. RaySearch is to deploy a new version of RayStation/RayPlan to correct the issue, to be released in April 2024. The provided Field Safety Notice is to be maintained with affected units. Consignees with any questions are to contact quality@raysearchlabs.com.

Root cause

Software design

Status

Open, Classified

Product code

MUJ

Quantity affected

128 units

Distribution

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hu

Date initiated

2024-03-28

Date posted

2024-05-01

Location

Stockholm, Sweden

Related 510(k) clearances