Class II — RAYSEARCH LABORATORIES AB
| Recalling firm | RaySearch Laboratories AB (publ) |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image. |
| Product | RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0. |
| Quantity | 251 units (148 units domestically & 103 units internationally) |
| Distribution | Worldwide Distribution - USA Nationwide in the states of: AZ, CA, CT, CO, DE, FL, IL, NJ, NY, MA, MD, MS, OH, PA, TN, VA and WA. and the countries of Australia, New Zealand, Belgium, New South Wales, Republic of Korea, Italy, Germany, China, France, Switzerland, Netherlands, Spain, Austria, United Kingdom and Norway. |
| Initiated | 2014-02-14 |
| Classified | 2014-04-21 |
| Terminated | 2017-02-15 |
| Recall number | Z-1481-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — RAYSEARCH LABORATORIES AB (Z-1481-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67535/
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