PlainRecalls
FDA Devices Moderate Class II Ongoing

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)

Reported: November 8, 2023 Initiated: September 12, 2023 #Z-0206-2024

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.

Details

Recalling Firm
RAYSEARCH LABORATORIES AB
Units Affected
2 sytems
Distribution
MD, TN
Location
Stockholm, N/A

Frequently Asked Questions

What product was recalled?
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). Recalled by RAYSEARCH LABORATORIES AB. Units affected: 2 sytems.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 8, 2023. Severity: Moderate. Recall number: Z-0206-2024.