Recall Z-2464-2023— RAYSEARCH LABORATORIES AB
Class II · Ongoing
Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2023-07-17. It names one FDA 510(k) clearance: K200487. 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. 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.
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-17
- Firm location
- Stockholm, N/A, Sweden
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.