medical Class II Updated 2023-11-01

EMPATICA SRL recalls Embrace2- Indicated for use as an adjunct to seizure monitor

Recalled 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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
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
View official government recall

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