Sonalleve Mr-hifu Fibroid Therapy (2016-04-28)
SONALLEVE MR-HIFU Fibroid Therapy Recall The SONALLEVE MR-HIFU system, a medical device used to treat uterine fibroids, is being recalled across Canada due to safety concerns that classify it as a Class I recall (the most serious type). This recall affects all units of this device that were distributed in Canada.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2016-05-16
- Status
- Closed
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ec1c1697-84b2-4dec-a73c-1cae875f4a50