S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, GE Healthcare, Wauwat
FDA device recall Z-1161-2008 · posted 2008-06-24 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Failure to alarm: An active monitor could become disconnected from the unit without any notification or alarm.
- Action taken
- 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
- Status
- Terminated
- Product code
- MSX
- Quantity affected
- 2146
- Distribution
- 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, Australi
- Date initiated
- 2007-12-13
- Date posted
- 2008-06-24
- Date terminated
- 2013-08-13
- Location
- Wauwatosa, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 (K052972) | GE Healthcare | 2005-12-29 |