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Health product recall

SENSE Body Coils for Philips Imaging System (2015-06-17)

Starting date:
June 16, 2015
Posting date:
July 8, 2015
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-54126

Recalled Product

  1. INTERA 1.5T MRI SYSTEM - SENSE BODY COIL
  2. ACHIEVA 1.5T MRI SYSTEM - SENSE BODY COIL
  3. GYROSCAN MAGNETIC RESONANCE IMAGING SYSTEM - ACS - NT
  4. ACHIEVA XR SYSTEM- SENSE BODY COIL

Reason

The instructions for use state how (and how not) to position the SENSE Body coil 1.5t and its cables in relation to the patient and Mr Bore in order to avoid a hazardous situation. When these instructions are not followed during an examination, the positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to RF coupling to the Quadrature Body Coil (QBC).

Affected products

A.INTERA 1.5T MRI SYSTEM - SENSE BODY COIL

Lot or serial number
  • 10183
  • 10236
  • 10566
  • 18861
  • 8240
  • 8256
  • 8379
  • 8442
  • 8734
  • 8985
Model or catalog number
  • 4522-132-1985X
  • 4522-132-7619X
  • 4598 000 5187X
  • 4598 000 5189X
Product UPC


 

Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands

B.ACHIEVA 1.5T MRI SYSTEM - SENSE BODY COIL

Lot or serial number

>10 NUMBERS, CONTACT MFG

Model or catalog number
  • 4522-132-1985X
  • 4598 000 5189X
Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands

C.GYROSCAN MAGNETIC RESONANCE IMAGING SYSTEM - ACS - NT

Lot or serial number
  • 5354
  • 5418
  • 5438
  • 5465
Model or catalog number
  • 452213219851
  • 452213219852
  • 452213219853
  • 452213219854
  • 452213219855
  • 452213219856
  • 452213219857
  • 452213219858
  • 452213276191
Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands

D.ACHIEVA XR SYSTEM- SENSE BODY COIL
 

Lot or serial number
  • 23015
  • 23031
  • 35054
  • 35062
Model or catalog number
  • 4598 000 5189X
Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC
Best, Netherlands

Date modified: