RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to supp

FDA device recall Z-2464-2023 · posted 2023-08-25 · Open, Classified

Recall details

Recalling firm

RAYSEARCH LABORATORIES AB

Reason for recall

An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances

Action taken

RaySearch issued Field Safety Notice, Medical Device Correction #119464 Letter via E-mail, on July 17, 2023. Letter states reason for recall, health risk and action to take: Manually verify the patient s medication list with respect to included substances when adding an new allergy to a medication substance. " Make sure to update all medications when activating a new version of the drug ingredients value set in the RayCare admin interface. " Educate staff and all users about the absence of a warning when adding a patient allergy. " Inspect your product and identify all installed units with the above software version number(s). " Confirm that you have read and understood this notice by replying to the notification email. SOLUTION This issue is resolved in the RayCare 2023B, market released in July 2023 (subject to market clearance in some markets) and future versions. 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

1 install

Distribution

US Nationwide distribution in the state of TN.

Date initiated

2023-07-17

Date posted

2023-08-25

Location

Stockholm, Sweden

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