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Embrace2- Indicated for use as an adjunct to seizure… recallZ-0159-2024 · Empatica Srl · initiated Jul 13, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Empatica Srl or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0159-2024
Status
Open, Classified
Initiated by the company
Jul 13, 2023
Posted by the FDA
Oct 24, 2023
Recalling firm
Empatica Srl
Quantity
1360 units
Product code
POS
FDA submissions
K181861
Distribution
Worldwide distribution - US Nationwide and the countries of Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, Sweden.

Product description

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 (models, lots, serial numbers)

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

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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