Recall Z-0159-2024— EMPATICA SRL
Class II · Ongoing
Class II FDA medical device recall by EMPATICA SRL, initiated 2023-07-13. It names one FDA 510(k) clearance: K181861. 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: May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently..
- Recalling firm
- EMPATICA SRL
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-13
- Firm location
- Milan, N/A, Italy
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.