RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation

FDA device recall Z-1310-2015 · posted 2015-03-20 · Terminated

Recall details

Recalling firm

RAYSEARCH LABORATORIES AB

Reason for recall

An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics.

Action taken

The firm, Raysearch Laboratories, sent a "Medical Device Correction/Field Safety Notice" and Reply Form(dated 3/3/2015) on 3/4/2015 via e-mail to the affected customers. The notice describes the product, problem and actions to be taken. The customers were instructed to deprecate any beam models that have been commissioned as DMLC capable for the affected linac types; do not commission beam models as DMLC capable for the affected linac types; educate physics staff and all users; inspect your system and identify all affected units of RayStation, acknowledge this notice by email or complete and return the Reply Form via fax to Americas market, RaySearch Americas Inc., at 888 501 7195, email: freddie.cardel@raysearchlabs.com or Rest of the world, RaySearch Laboratories AB, to email support@raysearchlabs.com. If you have any questions, contact Quality and Regulatory Affairs Manager, at +46 722 366 110 or email david.hedfors@raysearchables.com.

Root cause

Under Investigation by firm

Status

Terminated

Product code

MUJ

Quantity affected

Domestic: 245 units

Distribution

Nationwide Distribution.

Date initiated

2015-03-04

Date posted

2015-03-20

Date terminated

2017-09-20

Location

Stockholm, Sweden

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