Recall Z-0159-2024 ยท POS Physiological Signal Based Seizure Monitoring System
EMPATICA SRL
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-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S
| Date | Oct 24, 2023 (initiated Jul 13, 2023) |
| Status | Open, Classified |
| Reason | May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently. |
| Root cause | Device Design |
| Action | Empatica S.r.l issued Field Safety Notice via email on 7/14/23. Letter states reason for recall, health risk and action to take: You can check your device lot number by: " From the Alert App On the home page of your MyEmbrace account on the right hand side of the screen you will see your Embrace Serial Number. The lot number is represented by the 5th, 6th and 7th digit of the serial number. " On the packaging of your device On the box that contained your Embrace2 there is an identification label (See picture below). The device Lot number is identified with the LOT symbol. In the picture below |
| Quantity | 1360 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181861 | Embrace Empatica S.r.l., Dec 20, 2018 |