Magnetom Aera (2021-08-30)
Magnetom Aera Recall Summary Siemens Healthineers is recalling Magnetom Aera MRI machines distributed in Canada because of a potential software issue that could affect image quality or patient safety during scans. This recall affects healthcare facilities across Canada that use this MRI equipment model. The FDA classified this as a Class I recall, indicating a serious potential health risk.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2021-09-10
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/bc5e2584-a66b-4267-9625-272504edd159