RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
Reported: May 8, 2024 Initiated: March 28, 2024 #Z-1747-2024
Product Description
RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
Reason for Recall
Potential for reported SSD to be too high.
Details
- Recalling Firm
- RAYSEARCH LABORATORIES AB
- Units Affected
- 18 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 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 18 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-1747-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11