Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients.
FDA Recall Z-1994-2009 · Posted 2009-09-01
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Recalling FirmGE Medical Systems Information Tecnology
Recall StatusTerminated
Product CodeMLD
Date Initiated2006-02-06
Date Terminated2012-05-17
Product Quantity873
Reason for Recall
GE 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 (HR) was displaying as ---(3 dashes) when the monitor was used continuously for 49 days without a cold start.
A missed alarm or missed HR value could cause a delay in recognition of a cardiac event that may result i
Firm Action
GE Healthcare Technologies issued a Marketing Bulletin "Ref: MB MS HKI 06007" dated February 6, 2006 to explain a software update.
Root Cause
Software design
Distribution Pattern
ITALY, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRASIL, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, IRAN, ISRAEL JORDAN, LITHUANIA, ITALY, MACEDONIA, MALAYSIA, MEXICO, NETHERLAND, NICARAGUA, NORWAY, POLAND, PORTUGAL PUERTO RICO, RUSSIA, SINGAPORE, SLOVAK IA, SOUTH AFRICA, SPAIN, SWEDEN, SYRIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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