Recall Z-1995-2009 ยท MLD Monitor, St Segment With Alarm
GE Medical Systems Information Tecnology
Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCCM 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.
| Date | Sep 1, 2009 (initiated Feb 6, 2006) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| Action | GE Healthcare Technologies issued a Marketing Bulletin "Ref: MB MS HKI 06007" dated February 6, 2006 to explain a software update. |
| Quantity | 507 |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022740 | DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE Datex-Ohmeda, Nov 14, 2002 |