GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05 and L-NETC05, Datex-Ohmeda Inc., P
FDA device recall Z-1039-2009 · posted 2009-04-06 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- GE Healthcare is providing information about two issues associated with iCentral L-NETO5 and L-NETC05 v4.3, 4.4, 4.5 and 5.0 when used in combination with Dash 2000, 3000, 4000 and 5000; Solar 7000, 8000, 8000M and 8000i; Eagle 3000 and 4000 and ApexPro. The iCentral does not provide audio or visual alarming for the following: A FIB, VT> and PVC(1) alarms when used with ApexPro and VT>2 and PVC
- Action taken
- Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated January 26, 2009 addressed to Healthcare Administrator/Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the safety issue, affected product details, safety instructions, product correction and contact information. Direct questions to GE Healthcare at 1-800-558-7044, Option 2 and ask for Technical Support or contact your local GE Healthcare Distributor.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MSX
- Quantity affected
- 2,146
- Distribution
- Worldwide Distribution, USA (and PR) including states of AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY,LA, ME, MI, MN, MS, MO, NH, NJ, NY, NC, OH, PA, SC, TX, VT, VA, WA, and WI and countries of AUSTRALI
- Date initiated
- 2009-01-26
- Date posted
- 2009-04-06
- Date terminated
- 2013-08-13
- Location
- Wauwatosa, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 (K052972) | GE Healthcare | 2005-12-29 |