RaySearch Ray Station recall: Software Issue
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Why was RaySearch Ray Station recalled?
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model#: 4.30; Version: 4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses
- Product
- RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 19 units (16 units domestically & 3 units internationally)
- Distribution
- OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,
- Recall date
- April 9, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)