Milan, N/A, Italy
EMPATICA SRL recalls
1 recall recorded since 2018, most recently on 13 July 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 July 2023
- Reason
- May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0159-2024
- Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-S
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.