Health product recall

RayStation (2018-09-18)

Starting date:
September 18, 2018
Posting date:
October 19, 2018
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-68044

Affected products

RayStation

Reason

Issue found with robust optimization in Raystation 4.5, Raystation 4.7, Raystation 5, Raystation 6 and Raystation 7. When using robust optimization functions the background dose is not taken into account, although in some cases it is displayed as such in the user interface. The user must be aware of this information to avoid creating treatment plans that are less robust than intended.

Affected products

RayStation

Lot or serial number

RayStation 4.5.0.19

RayStation 4.5.1.14

RayStation 4.5.2.7

RayStation 4.7.0.15

RayStation 4.7.1.10

RayStation 4.7.2.5

RayStation 4.7.3.13

RayStation 4.7.4.4

RayStation 4.7.5.4

RayStation 5.0.0.37

RayStation 5.0.1.11

RayStation 5.0.2.35

RayStation 6.0.0.24

RayStation 6.1.0.26

RayStation 6.1.1.2

RayStation 6.2.0.7

RayStation 7.0.0.19

Model or catalog number

4.5

4.7

5

6

7

Companies
Manufacturer

RaySearch Laboratories AB (PUBL)

Sveavagen 25

Stockholm

11134

SWEDEN