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Health product recall

GE MAGNETIC RESONANCE SYSTEMS (2015-09-01)

Starting date:
September 1, 2015
Posting date:
September 29, 2015
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-55128

Recalled Products

  1. 3.0T SIGNA HDX MR SYSTEM - MAIN UNIT
  2. DISCOVERY MR750 MR SYSTEM - MAIN UNIT
  3. DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING

Reason

The predicted Head SAR value from the modeling, when using GE Healthcare 3.0t MR scanners with the whole body RF transmit coil and receive-only surface coils for head and/or neck imaging, suggests that actual SAR delivered to the head could potentially exceed the 3.2 W/kg SAR limit defined in iec60601-2-33. This issue does not affect MR scans performed outside the head and neck areas.

Affected products

A. 3.0T SIGNA HDX MR SYSTEM - MAIN UNIT

Lot or serial number
  • 00000279069MR9
  • 00000HDMR10727
Model or catalog number
  • M3335JJ
Companies
Manufacturer
Ge Medical Systems LLC
3200 North Grandview Blvd
Waukesha
UNITED STATES

B. DISCOVERY MR750 MR SYSTEM - MAIN UNIT

Lot or serial number
  • 000000000R2726
  • 00000291008MR1
  • 00000291154MR3
  • 00000296200MR9
  • 00000296265MR2
  • 00000298951MR5
  • 00000299547MR0
  • 00000300563MR4
  • 00000300711MR9
  • 00000303327MR1
Model or catalog number
  • M7000BD
Companies
Manufacturer
Ge Medical Systems LLC
3200 North Grandview Blvd
Waukesha
UNITED STATES

C. DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING

Lot or serial number
  • 00000000UA0010
  • 00000000UA0042
  • 00000000UA0364
  • 663
Model or catalog number
  • DISCOVERY MR750W 3.0T
Companies
Manufacturer
Ge Medical Systems LLC
3200 North Grandview Blvd
Waukesha
UNITED STATES

Date modified: