RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as w

FDA device recall Z-0206-2024 · posted 2023-11-01 · Open, Classified

Recall details

Recalling firm

RAYSEARCH LABORATORIES AB

Reason for recall

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MUJ

Quantity affected

2 sytems

Distribution

MD, TN

Date initiated

2023-09-12

Date posted

2023-11-01

Location

Stockholm, Sweden

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