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.
Reported: September 2, 2020 Initiated: July 29, 2020 #Z-2899-2020
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.
Details
- Recalling Firm
- RAYSEARCH LABORATORIES AB
- Units Affected
- N/A
- Distribution
- US Nationwide distribution including in the state of Tennessee.
- Location
- Stockholm, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by RAYSEARCH LABORATORIES AB. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 2, 2020. Severity: Moderate. Recall number: Z-2899-2020.
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