Recall MonitorHealth Products
SEMA 3
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: SEMA 3
Issue: Medical devices - Device compatibility
What to do: Contact the manufacturer if you require additional information.
Audience: Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| SEMA 3 | Not applicable. | 6020.009411 |
| SEMA 3 | Not applicable. | 6020.012099 |
| SEMA 3 | Not applicable. | 6020.009412 |
Issue
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.