Health product recall

MAGNETOM Scanners

Last updated

Summary

Product
MAGNETOM Scanners
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

MAGNETOM Cima.X

Not applicable.

11689304

MAGNETOM Cima.X

Not applicable.

11647158

MAGNETOM Cima.X Fit

Not applicable.

11647159

MAGNETOM Flow.Elite

Not applicable.

11851911

MAGNETOM Flow.Elite

Not applicable.

11878345

MAGNETOM Skyra Fit

Not applicable.

11516217

MAGNETOM Avanto Fit

211077

11516216

MAGNETOM Avanto Fit

211206

11516216

MAGNETOM Avanto Fit

211050

11516216

MAGNETOM Avanto Fit

211139

11516216

MAGNETOM Avanto Fit

211067

11516216

MAGNETOM Avanto Fit

211097

11516216

Issue

A software issue has been identified in syngo.via MR Cardiac Analysis MR Flow Quantification affecting the evaluation of retrospectively gated 2D cardiac flow data.

- The algorithm does not correctly represent the final phase of the cardiac cycle. The evaluation stops at the last trigger time point (TT point), which marks the beginning of the final cardiac phase, instead of accounting for the complete duration of that phase until the end of the cardiac cycle. The final repetition-time interval (TR) is not included in the calculation (“TR missing”). This results in systematic truncation of the cardiac cycle and incomplete loop closure.
- Consequently, flow quantification parameters (e.g., Forward volume, Avg.Flow/Min) are systematically underestimated. 
- The impact is relevant for Beat Sensor-triggered flow data, for which the flow peak occurs in the very last acquired cardiac phases.

The impact is minor or negligible for electrocardiogram (ECG)-triggered flow data, for which the flow values are close to zero in the very last acquired cardiac phases.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Siemens Healthcare Gmbh

Henkestr. 127, Erlangen, Germany, 91052

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82908

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