Mevatron, Oncor and Artiste Linear Accelerators (2017-01-31)

Starting date:

January 31, 2017

Posting date:

February 14, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Hospitals

Identification number:

RA-62206

• Reason
• Affected products

Affected Products

1. Mevatron Linear Accelerators
2. Oncor Expression Digital Linear Accelerator
3. Artiste MV-Linear Accelerator-Main Unit

Reason

It has come to our attention that for digital linear accelerators of type Artiste, Oncor and Primus with serial numbers equal or higher than 3094:

1. Incorrect values for the rotational collimator position may be displayed due to mechanical problems of the sensor slide.
2. The overhead suspension might break due to an improper weld seam, which might result in an injury of the patient.

Affected products