GE Healthcare CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1, MP100 Hardware). The CIC Pro" clinical Information Center central station is intended to collect information from a network and display this date. This data includes physiological, patient dermographic and/or other non-medical information.
FDA Recall Z-1600-2009 · Posted 2009-09-04
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Recalling FirmGE Medical Systems Information Tecnology
Recall StatusTerminated
Product CodeDSI
Date Initiated2009-03-10
Date Terminated2012-10-16
Product Quantity352
Reason for Recall
GE Healthcare has become aware of a potential issue associated with the failure to restart CARESCAPE CIC Pro v5.1 on the MP100 hardware. This issue may impact patient safety.
Firm Action
A GE Healthcare "Urgent Medical Device Correction" letter dated February 24, 2009 was sent to consignees. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Affected units will be replaced with new units by
GE Field Service team members.
For questions regarding this notice or experience a failure to restart the device, please contact GE Healthcare Technologies Support Center at 1-800-558-7044, enter Option 2 and ask for Technical Support or your local GE Field Service Representative.
Root Cause
Component change control
Distribution Pattern
Worldwide Distribution -- US (states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD,KY, MI, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OK, PA, RI, TN, TX, VA, WA, WV and WI), AUSTRIA, AUSTRALIA, CANADA, CZECH REPUBLIC, GERMANY, EGYPT, SPAIN, FRANCE, GREAT BRITAIN, ITALY, POLAND and SWEDEN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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