The Recall Desk
HighFDA (Devices)·Z-2464-2023·Announced 2023-09-06

Oncology Software Allergy Warnings May Not Display for Medication Ingredients

RayCare oncology software versions 5A, 5B, and 6A may fail to display medication allergy warnings under certain circumstances. Healthcare facilities could inadvertently prescribe medications patients are allergic to.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device with a functional defect affecting allergy warning displays for medication substances. While no illnesses or injuries have been reported, the theoretical risk of harm is significant—patients could inadvertently receive medications they are allergic to. Per the rubric, hazards without reported injuries but with clear potential for harm score at most 3 (High).

Plain-English summary

RayCare is an oncology information system software developed by RaySEARCH LABORATORIES AB. Versions 5A, 5B, and 6A (including service packs) support workflows, scheduling, clinical information, and treatment management in oncology care. A defect has been identified in these versions: under certain circumstances, the system fails to display medication allergy warnings.

The affected software is distributed in Tennessee. Healthcare providers and cancer treatment centers using these software versions may inadvertently prescribe medications to patients who have documented allergies to specific drug ingredients, as the system will not display the necessary safety alerts under certain conditions.

RaySEARCH LABORATORIES AB is recalling the affected software versions. Healthcare facilities currently using RayCare 5A, 5B, or 6A should contact the manufacturer for updated versions or service packs that address this defect. Until the issue is resolved, clinicians should manually verify patient medication allergy information before prescribing.

The recalled product

Product
RayCare software, include version number 5A, 5B, 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. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2,
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Oncology Information System
Hazard
  • allergy-warning
  • medication-allergen

Distribution

Distributed nationwide across the United States.

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