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 | Ongoing |
| Reason | A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant. |
| Product | RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs. |
| Quantity | 154 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hong Kong S.A.R., Hungary, India, Indonesia, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, P.R. China, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, T… |
| Initiated | 2024-02-23 |
| Classified | 2024-04-05 |
| Recall number | Z-1482-2024 |
| 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-1482-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94153/
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