SYNGO IMAGING - SYSTEM IUK
Brand(s)
Last updated
Summary
Product
SYNGO IMAGING - SYSTEM IUK
Issue
Medical devices - Inaccurate test or measurement results
What to do
Contact the manufacturer if you require additional information
Affected products
Affected Products |
Lot or serial number |
Model or catalog number |
|---|---|---|
SYNGO IMAGING - SYSTEM IUK |
1414 |
10 014 063 |
Issue
|
MRI images with certain values in the Dicom tags rescale slope (0028,1053) and rescale intercept (0028, 1052) can show wrong statistical values 'min/max' (maximum and minimum grayscale value in the ROI) and 'Mean/STD D' (mean value and standard deviation of the grayscale values) in the ROI, which can lead to an inconsistent, conflicting holistic view on the patient. Recall start date: 2021-09-29 |
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
SIEMENS HEALTHCARE LIMITED
1577 NORTH SERVICE ROAD EAST, OAKVILLE
ON, CANADA
L6H 0H6
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63613
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