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Terminated

GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems

FDA Recall Z-0519-2008 · Posted 2008-01-17

Recalling FirmGeneral Electric Medical Systems Information Technology
Recall StatusTerminated
Product CodeDSI
Date Initiated2007-11-08
Date Terminated2011-12-10
Product Quantity3, 116

Reason for Recall

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.

Firm Action

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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062976MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTERGe Medical Systems Information Technologies · 2007-03-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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