CanadaSEMA 3 cardiac signal processing software by Schiller AG (models/catalogue numbers 6020.009411, 6020.012099, 6020.009412) is affected. When an ECG is acquired with DEFIGARD Touch 7 or ARGUS PRO LifeCare 3 using the newest device software, SEMA may show a discrepancy because it inadequately processes an already filtered signal; SEMA should be updated to version 25.10. Contact the manufacturer for additional information.
What's being recalled
Companies: Schiller Ag, Altgasse 68, Baar, Zug, Switzerland, 6341.
How to identify it
Affected products: SEMA 3; Lot or serial number: Not applicable.; Model or catalogue number: 6020.009411
Affected products: SEMA 3; Lot or serial number: Not applicable.; Model or catalogue number: 6020.012099
Affected products: SEMA 3; Lot or serial number: Not applicable.; Model or catalogue number: 6020.009412
The hazard
When an ECG is aquired with DEFIGARD Touch 7 or ARGUS PRO LifeCare 3 with the newest software, there might be a discrepancy between the aquiring device and SEMA. This results from inadequate processing by SEMA to an already filtered signal. SEMA should be updated to version 25.10.
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)