Neoblue Mini LED Phototherapy System, Neoblue LED Therapy Device, Neoblue Cozy, Blanket, And Compact LED Phototherapy System (2018-04-08)
Recall Summary Neonatal phototherapy devices and blankets manufactured by Natus Medical (neoBLUE mini, neoBLUE, neoBLUE Cozy, Blanket, and Compact LED Phototherapy System models) are being recalled across Canada because they don't meet required safety and performance standards for medical devices. These devices are used to treat newborn jaundice by delivering light therapy. The recall affects all units of these products that were distributed throughout Canada.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2018-05-01
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/343b683a-5126-4716-aebb-7cd243d747f0