Recall Z-2211-2010 ยท MSX System, Network And Communication, Physiological Monitors
Ge Healthcare, Llc
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 sev
| Date | Aug 12, 2010 (initiated Jun 25, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| 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, COLOMB |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052972 | DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 GE Healthcare, Dec 29, 2005 |