Recall archive / FDA device enforcement
RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, a... — FDA record Z-0206-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 12, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- 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.
- Classification
- Class II
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 2 sytems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0206-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
MD, TN
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 8, 2023
- Recall initiation date
- Sep 12, 2023
- Center classification date
- Nov 1, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.