Terminated

S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, GE Healthcare, Wauwatosa, WI 53226.

FDA Recall Z-1161-2008 · Posted 2008-06-24

Recalling FirmGE Healthcare

Recall StatusTerminated

Product CodeMSX

Date Initiated2007-12-13

Date Terminated2013-08-13

Product Quantity2146

Reason for Recall

Failure to alarm: An active monitor could become disconnected from the unit without any notification or alarm.

Firm Action

Consignees were notified via a Medical Device Correction letter on 12/13/07. The letter explained the circumstances in which the "connection to monitor loss" alarm would not display, if a monitor was disconnected. The letter also included an attachment entitled "How to ensure a 'Connection to monitor lost' alarm on iCentral." For additional information, contact 1-800-558-7044.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution including USA states of AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, PA, SC, TN, TX, VA, VT, WA and WI; and countries of Algeria, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Guans, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libyan, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Yemen.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052972DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3GE Healthcare · 2005-12-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.