RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling...

FDA Device Recall #Z-2899-2020 — Class II — July 29, 2020

Recall Summary

Recall Number Z-2899-2020
Classification Class II — Moderate risk
Date Initiated July 29, 2020
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm RAYSEARCH LABORATORIES AB
Location Stockholm, N/A
Product Type Devices
Quantity N/A

Product Description

RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.

Reason for Recall

When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting the task, an error message might be displayed stating: Review files not available.

Distribution Pattern

US Nationwide distribution including in the state of Tennessee.

Lot / Code Information

Model #: 2C SP2, 2C SP3, 3A SP1, 3B and 4A Software Version: 2.2.2.30782 , 2.2.3.53423 , 3.0.1.43597 , 3.1.0.60341 , 4.0.0.60621"

Other Recalls from RAYSEARCH LABORATORIES AB

Recall # Classification Product Date
Z-1110-2026 Class II Brand Name: RayStation Product Name: RayStatio... Nov 28, 2025
Z-1106-2026 Class II Brand Name: RayStation Product Name: RayStatio... Nov 28, 2025
Z-1109-2026 Class II Brand Name: RayStation Product Name: RayStatio... Nov 28, 2025
Z-1104-2026 Class II RayStation/RayPlan. Model/Catalog Numbers: 12.0... Nov 28, 2025
Z-1108-2026 Class II Brand Name: RayStation Product Name: RayStatio... Nov 28, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.