RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Reported: April 9, 2014 Initiated: February 6, 2014 #Z-1308-2014
Product Description
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Reason for Recall
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
Details
- Recalling Firm
- RAYSEARCH LABORATORIES AB
- Units Affected
- 19 units (16 units domestically & 3 units internationally)
- Distribution
- OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,
- Location
- Stockholm, N/A
Frequently Asked Questions
What product was recalled? ▼
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 19 units (16 units domestically & 3 units internationally).
Why was this product recalled? ▼
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 9, 2014. Severity: Moderate. Recall number: Z-1308-2014.
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