FDA recall Z-0159-2024

EMPATICA SRL · Class II · device

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

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.

Key facts

Status
Ongoing
Initiation date
2023-07-13
Report date
2023-11-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Milan, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0159-2024