5, 6, 7 Software Cl II Ray Station 4.9

Company:RAYSEARCH LABORATORIES AB
Date of Enforcement Report 4/4/2018
Class lI:

PRODUCT

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
Recall Number Z-1275-2018

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

RECALLING FIRM/MANUFACTURER
RAYSEARCH LABORATORIES AB, Stockholm, Sweden on 3/29/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2484

DISTRIBUTION
Nationwide

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.