RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Servi
FDA device recall Z-2488-2025 · posted 2025-09-02 · Open, Classified
Recall details
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Reason for recall
- DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
- Action taken
- RaySearch notified consignees on about 08/08/2025 via email. Consignees were informed that as temporary solution, affected objects can be re-exported via RayGateway to generate new UIDs. They were instructed to inform planning staff and all users about this workaround, inspect your product and identify all installed units with the above software version number(s), and complete and return the response form. The issue will be resolved in the next version of RayStation, scheduled for market release in December 2025 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MUJ
- Quantity affected
- 2
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong
- Date initiated
- 2025-08-08
- Date posted
- 2025-09-02
- Location
- Stockholm, Sweden
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RayStation (K190387) | RaySearch Laboratories AB (PUBL) | 2019-06-19 |