Health product recall

SYNGO IMAGING - SYSTEM IUK

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
1457

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: 2021-11-19
Alert / recall type
Health product recall
Category
Health product - Medical device - 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