EMPATICA SRL recalls Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthca…

Recall date

July 13, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0159-2024

FDA classification

Class II

Brand / firm

EMPATICA SRL

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, Sweden.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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