GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems
Recall
- Recall Number
- Z-0519-2008
- Event Number
- 45913
- Firm
- General Electric Medical Systems Information Technology
- Product Code
- DSI
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 8, 2007
- Posted
- January 17, 2008
- Terminated
- December 10, 2011
- Address
- 9900 Innovation Drive, Mail Stop: RP2138, Wauwatosa, WI, 53226
Description
GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems
Potential for Loss of Audible Alarming and ECG Tab Setting Changes; from Clinical Informaiton Center (CIC) Pro v5.0.3 & 5.0.6 when used in combination with Telemetry and bedside monitors.
A "GE Urgent Medical Device Correction" letter was sent to consignees on 10/16/2007. The letter described the problem and product involved. The letter also gave short term recommendations. A long term solution is being worked on by GE and will be announced when determined.
Worldwide-USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, and District of Columbia and countries of The United Kingdom, Turkey, Thailand, Tsiwan, Syria , Switzerland, Sweden, Spain, Slovenia, Singapore, Saudi Arabia, Russia, Poland, Qatar, Pakistan, Philippines, Palestinian Territory, New Zealand, Norway, Netherlands, Nigerie, Malaysia, Lebanon, Jordan, Italy, Israel , Ireland, India, Honk Kong, Greece, Germany, France, Finland, Egypt, Denmark, Czech Republic, Cyprus, Costa Rica, Colombia,China, Chile, Canada, Delgium, Bahamas, Austria, and Australia.
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