Combolab System - Main Unit, Cardiolab System - Main Unit, Mac-lab System - Main Unit, And Mac-lab Systems - Integrated Electronics Box (2018-06-14)
Recall Summary General Electric is recalling certain CardioLab, ComboLab, and Mac-Lab medical system units distributed across Canada because they may malfunction due to a software issue. These devices are used in hospitals and clinics to monitor and record heart activity and other cardiac functions. The recall affects the main units and integrated electronics boxes manufactured before a certain date.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2018-07-27
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b4909278-5673-4c00-9bae-0fd22d4b6132