Recall Z-2211-2010
Ge Healthcare, Llc · initiated June 25, 2010
Product
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 ( Datek-Ohmeda Network and iCentral (including iCentral Client)) The Datex-Ohmeda Network and iCentral (including iCentral Client) transfers information between networked Datex-Ohmeda devices in the Monitor Network as well as between Monitor Network and networked devices in GE Unity NetworkTM. It also allows information transfer between several iCentrals. Within one Monitor Network it allows a networked device to display, store, print and otherwise process information received from other networked devices. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in Monitor Network. Network connections consist of hardwired network cables and/or Wireless LAN (WLAN) connections. Furthermore, it coordinates the transfer of information between devices in the Datex-Ohmeda Network, between the Datex-Ohmeda Network and devices in GE Unity Network as well as between the Datex-Ohmeda Network and Hospital Information Systems (HIS). The iCentral can be used for remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The iCentral Client can be used for remote monitor management, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is for use by qualified personnel only.
Codes / lots: Parent SN CZC53003BQ CZC53003BR CZC53003BX CZC7414GJD CZC7414GLN CZC5510Y64 CZC721500D CZC7272RM2 CZC7414GFS CZC7520S3Y CZC53003B3 CZC53003B8 CZC53003B9 CZC7520S16 CZC7520S18 CZC6322Q7L CZC64511L8 CZC84095RN FRB4210XQ9 FRB4210XQZ FRB4260139 CZC5240Q1L CZC5472F8J CZC6482WKL CZC73312RN CZC6130L3B CZC6261MW4 CZC6261MWZ CZC5280BS7 CZC94890SW CZC7520RZ0 CZC7520S2X CZC5240Q1G GB8627CX31 CZC642559Z CZC5391VGL 5100648 5100649 5100650 5100651 5100653 5100654 5100655 5115314 5123573 5123574 5123575 5123578 5132670 5132671 5132672 5132673 5132674 5132675 5132676 5132677 5132678 5132679 5132680 5132681 5140814 5148398 5148399 5148404 5148405 5148406 5148407 5148408 5156076 5156077 5156078 5156079 5156080 5156081 5156284 5165853 5165868 5171824 5173135 5178892 5178893 5178894 5178895 5178896 5178898 5178899 5178900 5182706 5182709 5182710 5182711 5182718 5199055 5199063 5199080 5213727 5213728 5213729 5213730 5213731 5213732 5213733 5213734 5213741 6161335 6186167 6299938 CZC7364RTL CZC7414GK1 CZC7520RZH CZC7520S49 CZC931344X CZC931344Z CZC7272RM6 FRB4250SZY CZC6181MT8 CZC64006K3 CZC6322Q85 CZC642559H CZC0044VYY CZC0044VZ5 CZC0044VZ7 CZC0044VZ8 CZC92520VB CZC92520VD CZC92520VL CZC62803TK…
Reason for recall
The iCentral or iCentral client v5.0.2 with HP xw 4400 and 4600 may spontaneously shutdown, causing monitoring loss at the central monitoring station. Monitoring loss may result in prolonged delay of treatment of potentially lethal arrhythmia.
FDA-determined cause: Software design
Action taken
GE Healthcare sent a "Urgent Medical Device Correction letter" dated 6/18/10 on 6/25/10 to consignees. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. The letter instructs consignees to follow specific detailed instructions for safe use of the device pending provision of a software upgrade by the firm. Consignees will be contacted by a GE Healthcare representative to schedule the software upgrade.
Details
- Recall number
- Z-2211-2010
- Initiated
- June 25, 2010
- Posted by FDA
- August 12, 2010
- Terminated
- August 14, 2012
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Quantity
- 2962
- Distribution
- AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MI, MN, MS, MO, NE, NH, NH, NY, NC, ND, OH, OK PA, RI, SC, TN, TX VT, VA, WA, WI. ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BARBADOS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE…
- Recalling firm
- Ge Healthcare, Llc, Waukesha, WI