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Health product recall

Discovery Nm/Ct (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-63600

Affected Products

  • A. Discovery Nm/Ct 570c
  • B. Discovery Nm/Ct 670 Pro
  • C. Discovery Nm/Ct 670
  • D. Discovery Nm/Ct 670 Es

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. Discovery Nm/Ct 570c

Lot or serial number

00000000019102

Model or catalog number

S8000RD

Companies
Manufacturer
GE Medical Systems Israel
Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL

B. Discovery Nm/Ct 670 Pro

Lot or serial number

000000SAN00776
27051
27081
27115
27124
PROV27146

Model or catalog number

H3100AD

Companies
Manufacturer
GE Medical Systems Israel
Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL

C. Discovery Nm/Ct 670

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

H3100JN

Companies
Manufacturer
GE Medical Systems Israel
Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL

D. Discovery Nm/Ct 670 Es

Lot or serial number

28008

Model or catalog number

H3100AE

Companies
Manufacturer
GE Medical Systems Israel
Functional Imaging
4 Hayozma Street
Tirat Hacarmel
0030200
ISRAEL