RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Reported: May 8, 2024 Initiated: March 28, 2024 #Z-1746-2024
Product Description
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Reason for Recall
Potential for reported SSD to be too high.
Details
- Recalling Firm
- RAYSEARCH LABORATORIES AB
- Units Affected
- 213 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.
- Location
- Stockholm
Frequently Asked Questions
What product was recalled? ▼
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 213 units.
Why was this product recalled? ▼
Potential for reported SSD to be too high.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2024. Severity: Moderate. Recall number: Z-1746-2024.
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