Public recall detail

Siemens Healthineers AG Magnetom and Biograph One Systems

2026-10-28

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Health products Health product recall
Quick summary

Quick summary: Siemens Healthineers AG Magnetom and Biograph One Systems. Reason: Health product recall. Category: Health products. Date: 2026-10-28.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Siemens Healthineers AG Magnetom and Biograph One Systems. Reason: Health product recall. Category: Health products. Date: 2026-10-28.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSiemens Healthineers Ag
ProductSiemens Healthineers AG Magnetom and Biograph One Systems
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82872

Affected products

ProductMagnetom Sola
LotMore than 10 numbers, contact manufacturer.
Model11291455
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionMagnetom Sola
ProductMagnetom Sola Fit
LotMore than 10 numbers, contact manufacturer.
Model11410482
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionMagnetom Sola Fit
ProductMagnetom Flow.Elite
Lot234786
Model11851911
Serial number234786
DescriptionMagnetom Flow.Elite
ProductMagnetom Flow.Elite
Lot234723
Model11851911
Serial number234723
DescriptionMagnetom Flow.Elite
ProductMagnetom Flow.Elite
Lot234827
Model11851911
Serial number234827
DescriptionMagnetom Flow.Elite
ProductMagnetom Flow.Elite
Lot234832
Model11851911
Serial number234832
DescriptionMagnetom Flow.Elite
ProductMagnetom Lumina
Lot196680
Model11344916
Serial number196680
DescriptionMagnetom Lumina
ProductBiograph One
Lot238015
Model11689172
Serial number238015
DescriptionBiograph One
ProductBiograph One
Lot238023
Model11689172
Serial number238023
DescriptionBiograph One
ProductMagnetom Vida Fit
Lot202203
Model11410481
Serial number202203
DescriptionMagnetom Vida Fit
ProductMagnetom Vida Fit
Lot202080
Model11410481
Serial number202080
DescriptionMagnetom Vida Fit
ProductMagnetom Vida
LotMore than 10 numbers, contact manufacturer.
Model11060815
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionMagnetom Vida
ProductMagnetom Viato.Mobile
Lot239040
Model11689652
Serial number239040
DescriptionMagnetom Viato.Mobile

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesSiemens Healthineers Ag Siemensstr. 3, Forchheim, Germany, 91301
Recall date2026-10-20
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82872
Background{}
CompaniesSiemens Healthineers Ag Siemensstr. 3, Forchheim, Germany, 91301
AudiencesHealthcare
Source updated2026-10-28

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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