Health product recall

RayStation & RayPlan (2019-11-18)

Starting date:
November 18, 2019
Posting date:
January 20, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72109



Last updated: 2020-01-21

Affected Products

  1. RayStation
  2. RayPlan

Reason

Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. This may happen in the following scenarios:

1. When editing or viewing a static arc beam with a cone using the edit beam dialog. The bug is triggered when closing the edit beam dialog with ok, even if no changes were made in the dialog.

2. When editing the aperture of a static arc beam using the polygon tool or the rectangular field tool. 

If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported. After recalculation the dose will be correct, but the beam weighting can be different than it was before the beam was edited, even if the beam weights were clamped (locked) in the beam weighting tab.

Affected products

A. RayStation

Lot or serial number

All lots.

Model or catalog number

4.0.3

5

6

7

Companies
Manufacturer

RaySearch Laboratories AB (PUBL)

Sveavagen 25

Stockholm

11134

SWEDEN


B. RayPlan

Lot or serial number

All lots. 

Model or catalog number

2

7

Companies
Manufacturer

RaySearch Laboratories AB (PUBL)

Sveavagen 25

Stockholm

11134

SWEDEN