The Recall Desk
ModerateFDA (Devices)·Z-2899-2020·Announced 2020-09-02

RayCare Oncology Software Recalled for Offline Image Review Error

RaySearch Laboratories AB is recalling RayCare oncology software due to an error message that may prevent users from accessing offline images during review tasks.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a software error that may impede workflow but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

RaySearch Laboratories AB is recalling RayCare stand-alone software, which is used to support workflows, scheduling, and clinical information management for oncology care. The recall involves specific software versions (2.2.2.30782, 2.2.3.53423, 3.0.1.43597, 3.1.0.60341, and 4.0.0.60621) and models (2C SP2, 2C SP3, 3A SP1, 3B, and 4A).

The recall is issued because an error message stating "Review files not available" may be displayed when performing offline image review in RayCare 2C, 3A, and 3B. This error can occur when the software attempts to guide the user to the image viewer with the treatment image related to the fraction and the planning image selected.

The affected software was distributed nationwide in the United States, including in the state of Tennessee. Users of the affected software versions should contact RaySearch Laboratories AB for further instructions on how to resolve the issue.

The recalled product

Product
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.
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Software
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • 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"

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

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