Z-0206-2024 Class II Ongoing

Recalled by RAYSEARCH LABORATORIES AB — Stockholm, N/A

Recall Details

Product Type
Devices
Report Date
November 8, 2023
Initiation Date
September 12, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 sytems

Product Description

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)

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.

Distribution Pattern

MD, TN

Code Information

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