RAYSEARCH LABORATORIES AB: Medical Device Recall in 2023 - (Recall #: Z-2464-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 17, 2023

Date Posted: September 6, 2023

Recall Number: Z-2464-2023

Event ID: 92777

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

Status: Ongoing

Product Quantity: 1 install

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.

Voluntary or Mandated:

Voluntary: Firm initiated