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
This recall is currently active, issued October 24, 2023. It was issued by Empatica Srl Via Enrico Stendhal.
- Company
- Empatica Srl Via Enrico Stendhal
- Recall Initiated
- July 13, 2023
- Posted
- October 24, 2023
- Recall Number
- Z-0159-2024
- Quantity
- 1360 units
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Lot / Code Info
UDI-DI: (1) Flamingo Pink EM2-FP-S - 00853858006133; (2) Sky Blue EM2-SB-2 - 00853858006140; (3) Seoul Grey EM2-SG-S - 00853858006126; (4) Boston Blue EM2-BB-S - 00853858006119; (5) Milan Black EM2-MB-S - 00853858006102 Lot Numbers: G11/H11
Root Cause
Device Design
Action Taken
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 the device Lot number is F11. Empatica recommends that you pay increased attention to the product battery level notifications intended to inform you about the remaining battery charge. As noted in the user manual, the Embrace device is not intended to be used as a stand-alone monitoring device. As the system is not meant to substitute for ongoing seizure monitoring practices, patients are strongly advised to ensure that alternative methods of obtaining medical assistance are available at all times, including during device charging sessions Patients are also encouraged to contact Empatica customer support for any concern related to battery life impacting usability of the Embrace device. Customers contacted by the Empatica customer support team regarding battery duration are offered a free-of-charge replacement device.