RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software

FDA device recall Z-1308-2014 · posted 2014-03-31 · Terminated

Recall details

Recalling firm

RAYSEARCH LABORATORIES AB

Reason for recall

RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.

Action taken

On February 6, 2014, RaySearch Laboratories distributed Urgent Medical Device Correction notices to their customers via email regarding the affected product. To determine if the version you are using is affected, bring up the About box in the RayStation application and check if the number reported is "4.0.2.9". If so, the notice applies to your version. Customers are advised to inform all planning staff and all users about the instructions listed on the notice. Customers are advised to inspect their system and identify all installed units with the referenced software version numbers listed on the notice. Corrective labeling is distributed to the customers in the form of the safety notification attached to this report and the software problem will be resolved in RayStation patch 4.0.3 scheduled for market release end of February 2014 and in all future releases. For further information and return of the reply form, please contact: Freddie Cardel, Director of Customer Support, RaySearch Americas, (877) 778-3849 or freddie.cardel@raysearchlabs.com.

Root cause

Software Design Change

Status

Terminated

Product code

MUJ

Quantity affected

19 units (16 units domestically & 3 units internationally)

Distribution

OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,

Date initiated

2014-02-06

Date posted

2014-03-31

Date terminated

2017-02-17

Location

Stockholm, Sweden

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