Health product recall

RayStation (2018-11-10)

Starting date:
November 10, 2018
Posting date:
November 30, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68498

Affected products

RayStation

Reason

This recall notice concerns an issue found with isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.

Affected products

RayStation

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

4.0.3
5
6
7

Companies
Manufacturer
RaySearch Laboratories AB (PUBL)
Sveavagen 25
Stockholm
11134
SWEDEN