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Recall Observatory FDA recall evidence

Device 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, 5.1.3, 6.0.0

Z-2464-2023

July 17, 2023

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 92777
Status
Ongoing
Classification
Class II
Quantity
1 install
Official record key
device-enforcement:Z-2464-2023

Official wording

Reason: 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

Code information: Product name (build number) UDI-DI RayCare 5A (5.0.0.60390) 0735000201039620210524 RayCare 5A SP1 (5.0.1.60052) 0735000201046420220305 RayCare 5B SP1 (5.1.1.60246) 0735000201053220220316 RayCare 5B SP2 (5.1.2.60028) 0735000201062420220613 RayCare 5B SP3 (5.1.3.60023) 0735000201069320221027 RayCare 6A (6.0.0.60553) 0735000201056320220617

Distribution pattern: US Nationwide distribution in the state of TN.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    issue was found in Software