DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 ( Datek-Ohmeda Network and iCentral (including iCentral Client
FDA device recall Z-2211-2010 · posted 2010-08-12 · Terminated
Recall details
- Recalling firm
- Ge Healthcare, Llc
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MSX
- Quantity affected
- 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, BAHRAI
- Date initiated
- 2010-06-25
- Date posted
- 2010-08-12
- Date terminated
- 2012-08-14
- Location
- Waukesha, 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 |