Health product recall

SYNGO.PLAZA

Last updated

Summary

Product
SYNGO.PLAZA
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.PLAZA

More than 10 numbers, contact manufacturer.

11293724

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: 2021-09-30

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-63612

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