FDA recall Z-1275-2018

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-01-26

Report date

2018-04-04

Termination date

2020-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stockholm, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1275-2018