Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCCM Indicated for
FDA device recall Z-1995-2009 · posted 2009-09-01 · Terminated
Recall details
- Recalling firm
- GE Medical Systems Information Tecnology
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- MLD
- Quantity affected
- 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
- Date initiated
- 2006-02-06
- Date posted
- 2009-09-01
- Date terminated
- 2012-05-17
- Location
- Wauwatosa, WI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE (K022740) | Datex-Ohmeda | 2002-11-14 |