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Recall Observatory FDA recall evidence

Device 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

Z-1275-2018

January 26, 2018

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 79582
Status
Terminated
Classification
Class II
Quantity
2484
Official record key
device-enforcement:Z-1275-2018

Official wording

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

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software issue with Center Beam in Field functionality. Issue