GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image analysis software package that all

FDA device recall Z-1720-2009 · posted 2009-08-13 · Terminated

Recall details

Recalling firm

GE Medical Systems, LLC

Reason for recall

GE Healthcare has recently become aware of the need to adjust default settings associated with the use of CT Perfusion 4 on the Advantage Workstation, ST and PET/CT consoles that may impact patient safety. The default parameter settings in CT Perfusion 4 may not be optimal in the case of data acquired with longer time sampling intervals such as axial scans with inter scan delay (ISD) greater th

Action taken

GE Healthcare issued an "Urgent Medical Device Correction" letter dated April 23, 2009. The letter was addressed to Hospital Administrators / Risk managers and Radiology department mangers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information instructing the user to follow the enclosed User Guide Addendum to mitigate further problems. For further questions, contact GE Healthcare at 1-800-437-1171 (US), 0120-055-919 (Japan); for other countries, contact your local GE Healthcare field service representative.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

444

Distribution

Worldwide Distribution -- Including states of AZ, CA, CT, DC, FL, HI, IL, IA, MA, MI, NJ, NY, NC, OK, PA, PR, TX, WA, WV and WI and countries of ARGENTINA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHI

Date initiated

2009-05-04

Date posted

2009-08-13

Date terminated

2012-05-16

Location

Waukesha, WI

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