RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Product name (build number): (1)RayCare 5B SP1 (5.1.1.60246); (2)RayCare 5B SP3 (5.1.3.60023); (3) RayCare 6A (6.0.0.60553) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Product name (build number): (1)RayCare 5B SP1 (5.1.1.60246); (2)RayCare 5B SP3 (5.1.3.60023); (3) RayCare 6A (6.0.0.60553)
Brand
RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden
Lot Codes / Batch Numbers
UDI-DI: (1)RayCare 5B SP1 (5.1.1.60246) 0735000201053220220316, (2)RayCare 5B SP3 (5.1.3.60023) 0735000201069320221027, (3) RayCare 6A (6.0.0.60553) 0735000201056320220617
Products Sold
UDI-DI: (1)RayCare 5B SP1 (5.1.1.60246) 0735000201053220220316; (2)RayCare 5B SP3 (5.1.3.60023) 0735000201069320221027; (3) RayCare 6A (6.0.0.60553) 0735000201056320220617
RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden is recalling RayCare 5B and 6A including service packs- An oncology information system used to support workflows due to An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with single- or multi-selectable values.
Recommended Action
Per FDA guidance
Raysearch issued Field Safety Notice, Medical Device Correction #121600 via email on 9/12/23. Letter states reason for recall, health risk and action to take: Educate staff and all users to open configurable documents from the Documents workspace to avoid the issue. " Review all configured documents and consider reconfiguration in a way that will not trigger the issue. " Inspect your product and identify all installed units with the above software version number(s). " Confirm you have read and understood this notice by replying to the notification email. Solution This issue will be resolved in the next version of RayCare, scheduled for market release in December 2023 (RayCare 2024A) (subject to market clearance in some markets). If customers wish to continue using versions of RayCare 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. For regulatory information, please contact quality@raysearchlabs.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MD, TN
Page updated: Jan 10, 2026