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
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