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EMPATICA SRL recalls Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcar
Recalled November 1, 2023 · FDA recall Z-0159-2024 · EMPATICA SRL
Hazard
May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently. · FDA Class II
Units
1360 units
Sold at
Worldwide distribution - US Nationwide and the countries of Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, Sweden.
Description
May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
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
Manufacturer(s)
EMPATICA SRL
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →