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GE Healthcare Finland Oy · Model Pre-conf. EEG Lead Set 2 General, 898051 · UDI-DI 00840682103442

MLDOMCMHXORTOLTGWJ Prescription
1
510(k) clearances
33
Adverse events (4 deaths)
2
Recalls
48
Facilities

Description

PRE-CONFIGURED EEG LEAD SET 2 GENERAL, 898051

Recalls

DateFirmReason
2006-02-06GE Medical Systems Information TecnologyGE Healthcare (Datex-Ohmeda) S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software had an issue where the Heart Rate
2006-02-06GE Medical Systems Information TecnologyGE Healthcare (Datex-Ohmeda) S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software had an issue where the Heart Rate

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.