Z-1275-2018 Class II Terminated
FDA device recall Z-1275-2018 was initiated by RAYSEARCH LABORATORIES AB on Jan 26, 2018 and is designated Class II. Reason for recall: Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient. The recall status is terminated (terminated Jan 13, 2020). Affected quantity: 2484.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 4, 2018
- Initiation Date
- Jan 26, 2018
- Termination Date
- Jan 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2484
Product Description
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 Pattern
Nationwide
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1275-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026