Health product recall

RayStation and RayPlan (2018-01-26)

Starting date:
January 26, 2018
Posting date:
March 13, 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-66120

Affected products

  1. RAYSTATION
  2. RAYPLAN

Reason

When more than one beam is defined on the same isocenter, Center Beam in Field (CBF) affects all beams in a way that the user may not expect. After using CBF, the resulting fields are clearly displayed in RayStation/RayPlan for review and approval. However, one mistreatment incident using the CBF functionality has been reported where the user failed to review the resulting beam apertures before treatment delivery.

Affected products

A. RAYSTATION

Lot or serial number

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

Model or catalog number

5

Companies
Manufacturer

RaySearch Laboratories AB (PUBL)

Sveavagen 25

Stockholm

11134

SWEDEN


B. RAYPLAN

Lot or serial number

Not applicable

Model or catalog number

2

Companies
Manufacturer

RaySearch Laboratories AB (PUBL)

Sveavagen 25

Stockholm

11134

SWEDEN