4 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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
FDA Recall
Open, Classified
·EMPATICA SRL Via Enrico Stendhal·Product code POS·July 13, 2023
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
FDA Recall
Open, Classified
·ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ul. Ks. Piotra Wawrzyniaka 2 Komorniki Poland·Product code FNL·August 29, 2023
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
FDA Recall
Open, Classified
·ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ul. Ks. Piotra Wawrzyniaka 2 Komorniki Poland·Product code FNL·August 29, 2023
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
FDA Recall
Open, Classified
·ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ul. Ks. Piotra Wawrzyniaka 2 Komorniki Poland·Product code FSA·March 10, 2026