Various Linear Accelerators Oncor Systems (2014-06-03)

Starting date:

June 3, 2014

Posting date:

July 7, 2014

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-40385

• Reason
• Affected products

Recalled Products

A) Mevatron Linear Accelerators
B) Oncor Expression Digital Linear Accelerator
C) Artiste MV - Linear Accelerator - Main Unit
D) Oncor Impression IMRT Plus

Reason

Siemens became aware of an incident with a Linear Accelerator Oncor where an auto sequence was set up with a treatment management system. During the auto sequence the gantry collided with the patient's head while moving. The patient received a wound on the head that resulted in skin injuries but no further damage. The user provided a detailed report in which he described that a mistake was made when selecting the beams for auto sequence. The user error caused the unintended motion and hence the injury.

Affected products