RayCare 3B Oncology Software Recalled for Data Loss During Upgrade
RaySearch Laboratories AB is recalling RayCare 3B software because patient messages may be lost when upgrading from RayCare 2.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device software) where data loss could impact patient care, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
RaySearch Laboratories AB is recalling the RayCare 3B (3.1.0.60341) oncology information system. This software is intended to support healthcare professionals in delivering cancer care.
The recall is due to a defect where patient-related messages created in RayCare 3B or RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later versions. This data loss could impact the continuity of patient care information.
The affected software has a serial number of 3.1.0.60341 and a UDI of 0735000201028020191220. The product was distributed nationwide in the United States, specifically in the state of Tennessee. Healthcare facilities using this software should contact the manufacturer for instructions on how to proceed with upgrades or data preservation.
The recalled product
- Product
- RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Category
- Medical Device — Software
- Hazard
- Affected units
- 1
Distribution
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