CanadaWhat's being recalled
Companies: Siemens Healthineers Ag, Siemensstr. 3, Forchheim, Germany, 91301.
How to identify it
Affected products: Magnetom Sola; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 11291455
Affected products: Magnetom Sola Fit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 11410482
Affected products: Magnetom Flow.Elite; Lot or serial number: 234786; Model or catalogue number: 11851911
Affected products: Magnetom Flow.Elite; Lot or serial number: 234723; Model or catalogue number: 11851911
Affected products: Magnetom Flow.Elite; Lot or serial number: 234827; Model or catalogue number: 11851911
Affected products: Magnetom Flow.Elite; Lot or serial number: 234832; Model or catalogue number: 11851911
Affected products: Magnetom Lumina; Lot or serial number: 196680; Model or catalogue number: 11344916
Affected products: Biograph One; Lot or serial number: 238015; Model or catalogue number: 11689172
Affected products: Biograph One; Lot or serial number: 238023; Model or catalogue number: 11689172
Affected products: Magnetom Vida Fit; Lot or serial number: 202203; Model or catalogue number: 11410481
Affected products: Magnetom Vida Fit; Lot or serial number: 202080; Model or catalogue number: 11410481
Affected products: Magnetom Vida; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 11060815
Affected products: Magnetom Viato.Mobile; Lot or serial number: 239040; Model or catalogue number: 11689652
The hazard
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 to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)