Terminated

GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6 ,5.0.7, 5.0.8 and 4.1. The CIC Pro" Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. The CIC Pro Central Station is intended to collect information from a network and display this data. This data included physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from GE Healthcare Information Technologies monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information central station. Beat to beat patient information for all parameters and waveforms from he bedsides and telemetry systems can be displayed. The CIC Pro Clinical Information Center central station supports the ability to access information from GE Medical Systems Information Technologies products in web browser format. Additionally, the CICC Pro clinical Information central station supports the ability to access patient information collected from the unity network and stored on a network server.

FDA Recall Z-1232-2009 · Posted 2009-05-04

Recalling FirmGE Medical Systems Information Tecnology

Recall StatusTerminated

Product CodeDSI

Date Initiated2009-02-27

Date Terminated2014-09-15

Product Quantity12,737

Reason for Recall

GE Healthcare is aware of potential network time issues associated with the time change aspects of certain CARESCAPE CIC Pro" software versions. These issues may impact patient safety. No reported patient injuries or illnesses for the use of this device in conjunction with this device correction.

Firm Action

Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated February 27, 2009. The letter was addressed to the Chief of Nursing/Chief of Biomedical Engineering and Risk Manager/Healthcare Administrator. The letter describes the Safety Issue, Affected Product Details, Safety instructions, Product Correction, and Contact Information. Direct questions to your local GE Healthcare Field Service Representative or the GE Healthcare Technologies Support Center by calling 1-800-558-7044 (Option 2, Technical Support).

Root Cause

Software design

Distribution Pattern

Worldwide Distribution including US (states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, DC, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, PR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WY, WI, and WV) and countries of UNITED ARAB EMIRATES, AUSTRIA, AUSTRALIA, BOSNIA AND HERZEGOVINA, BANGLADESH, BELGIUM, BRAZIL, BAHAMAS, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, COSTA RICA, CUBA, CYPRUS, CZECH REPUBLIC, GERMANY, ESTONIA, EGYPT, SPAIN, FINLAND, FRANCE, GHANA, GREECE, HONG KONG, HUNGARY, HONDURAS, INDONESIA, IRELAND, ISRAEL, INDIA, IRAQ, BRITISH INDIAN OCEAN TERRITORY, ITALY, JORDAN, JAPAN, SOUTH KOREA, KUWAIT, LEBANON, LITHUANIA, MALTA, MEXICO, MALAYSIA, NIGERIA, NETHERLANDS, NORWAY, NEPAL, NEW ZEALAND, PANAMA, PERU, PHILIPPINES, PAKISTAN, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SUDAN, SW DEN, SINGAPORE, SLOVENIA, SLOVAK REPUBLIC, SYRIA, THAILAND, TURKEY, TRINIAD, TOBAGO, TAIWAN, UKRAINE, UNITED KINGDOM, VENEZUELA, YEMEN, and SOUTH AFRICA.

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 K053356MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATIONGe Medical Systems Information Technologies · 2006-04-19 K032370CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATIONGe Medical Systems Information Technologies · 2003-08-13

Official Source

View FDA Recall →

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