Health product recall

Siemens Healthineers AG Magnetom and Biograph One Systems

Last updated

Summary

Product
Siemens Healthineers AG Magnetom and Biograph One Systems
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 Sola

More than 10 numbers, contact manufacturer.

11291455

Magnetom Sola Fit

More than 10 numbers, contact manufacturer.

11410482

Magnetom Flow.Elite

234786

11851911

Magnetom Flow.Elite

234723

11851911

Magnetom Flow.Elite

234827

11851911

Magnetom Flow.Elite

234832

11851911

Magnetom Lumina

196680

11344916

Biograph One

238015

11689172

Biograph One

238023

11689172

Magnetom Vida Fit

202203

11410481

Magnetom Vida Fit

202080

11410481

Magnetom Vida

More than 10 numbers, contact manufacturer.

11060815

Magnetom Viato.Mobile

239040

11689652

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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Siemens Healthineers Ag
Siemensstr. 3, Forchheim, Germany, 91301
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82872

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