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
Reported: April 4, 2018 Initiated: January 26, 2018 #Z-1275-2018
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.
Details
- Recalling Firm
- RAYSEARCH LABORATORIES AB
- Units Affected
- 2484
- Distribution
- Nationwide
- Location
- Stockholm
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 2484.
Why was this product recalled? ▼
Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 4, 2018. Severity: Moderate. Recall number: Z-1275-2018.
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