RayStation Version 2.0.0.15 Consult instruction for use. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Swe

FDA device recall Z-0359-2012 · posted 2011-12-02 · Terminated

Recall details

Recalling firm

RAYSEARCH LABORATORIES AB

Reason for recall

The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual. The symptoms involve the Pixel Spacing and Image Position attributes in the RT images being incorrect, thus enabling the user to make measurements that are erroneous and possibly misalign the patient.

Action taken

The firm, RaySearch Laboratories, sent an email with an "Urgent Field Safety Notice Medical Device Correction" notice dated October 19, 2011 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to pass on the information in the field safety notice to everyone involved and create routines to compensate for the incorrect DRR images; if the DICOM DRR images are not used to make any form of absolute measurements, no action needs to be taken. Raysearch laboratories will provide a script to update these DICOM files to have the correct values upon request. For further information please contact RaySearch Laboratories AB Quality and Regulatory Affairs Manager at +46 722 366 110 or david.hedfors@raysearchlabs.com; RaySearch Americas Director of Customer Support at +1 877 778 3489 or freddie.cardell@raysearchlabs.com.

Root cause

Device Design

Status

Terminated

Product code

MUJ

Quantity affected

19 units

Distribution

Worldwide distribution: USA (nationwide) including states of: MA, NJ, and NY; and country of: Netherlands

Date initiated

2011-10-19

Date posted

2011-12-02

Date terminated

2012-05-11

Location

Stockholm, Sweden

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