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U.S. Department of Health and Human Services

Class 2 Device Recall Embrace

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  Class 2 Device Recall Embrace see related information
Date Initiated by Firm July 13, 2023
Date Posted October 24, 2023
Recall Status1 Open3, Classified
Recall Number Z-0159-2024
Recall Event ID 93215
510(K)Number K181861  
Product Classification Physiological signal based seizure monitoring system - Product Code POS
Product 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
Code Information 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
Recalling Firm/
Manufacturer		 EMPATICA SRL
Via Enrico Stendhal 36
Milan Italy
Manufacturer Reason
for Recall		 May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = POS and Original Applicant = Empatica Srl
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