EMPATICA SRL: 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

Hazard

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

Details from the source

Reason for recall: May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently. Distribution: Worldwide distribution - US Nationwide and the countries of Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, Sweden. Quantity: 1360 units 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

UPC codes

00853858006133, 00853858006140, 00853858006126, 00853858006119, 00853858006102

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.