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Health product recall

Brightspeed Scanner Systems (2017-06-01)

Starting date:
June 1, 2017
Posting date:
June 13, 2017
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-63604

Affected Products

  • A. Brightspeed Elite Computed Tomography (CT) Scanner System
  • B. Brightspeed Excel CT Scanner System

Reason

GE Healthcare has recently become aware of a potential safety issue that can result in a scan starting before the prescribed delay has completed. More specifically, if an exam is interrupted during the prep delay period using the emergency stop button and the scan is then resumed, the delay period may be shorter than expected. If personnel are in the scan room at the time of the premature scan initiation they can be exposed to scatter x-ray radiation.

Affected products

A. Brightspeed Elite Computed Tomography (CT) Scanner System

Lot or serial number
  • 00000010521YC3
  • 00000014437YC8
  • 00000014742YC1
  • 00000190682HM5
  • 00000274620HM4
  • 00000275150HM1
  • 00000290180HM9
  • 00000296311HM4
  • 00000303205HM9
  • 00000306621HM4
Model or catalog number

BRIGHTSPEED ELITE

Companies
Manufacturer
GE Hangwei Medical Systems Co. Ltd.
WEST AREA OF BLDG. NO.3, NO.1 YONGCHANG NORTH ROAD, BEIJING, ECONOMIC & TECHNOLOGICAL DPVMT ZONE
Beijing
100176
CHINA

B. Brightspeed Excel CT Scanner System

Lot or serial number

00000159655HM0

Model or catalog number

S7904BD/BZ

Companies
Manufacturer
GE Hangwei Medical Systems Co. Ltd.
WEST AREA OF BLDG. NO.3, NO.1 YONGCHANG NORTH ROAD, BEIJING, ECONOMIC & TECHNOLOGICAL DPVMT ZONE
Beijing
100176
CHINA

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