ACHIEVA 3.0T MRI, CT, AND XR SYSTEMS (2016-10-12)

Starting date:

October 12, 2016

Posting date:

November 3, 2016

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-60802

• 
  Reason
• 
  Affected products

Affected Products

1. ACHIEVA 3.0T MRI SYSTEM - MAIN UNIT
2. ACHIEVA XR SYSTEM - MAIN UNIT
3. INGENIA 3.0T
4. INGENIA 3.0T CX

Reason

The thickness and location of the shielding material must be installed according to the shielding requirements provided by Philips. In cases where the requirements are not followed, the distance between the passive shielding rear wall and the magnet could be insufficient. An insufficient distance leads to stronger attraction forces between the magnet and the passive shielding. These stronger forces may lead to shearing of the magnet vibration pads. In a worst case scenario, it may result in displacement of the magnet. Displacement of a magnet can result in image quality issues and mechanical fitting problems with the table. These functional issues affect the clinical usage of the MRI System.

Affected products