GE Medical Systems, LLC GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image analysis software package that allows the user to produce image data and to generate information with regard to changes in image intensity over time supporting CT Perfusion images. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image analysis software package that allows the user to produce image data and to generate information with regard to changes in image intensity over time supporting CT Perfusion images.
Brand
GE Medical Systems, LLC
Lot Codes / Batch Numbers
Serial Numbers: 00000152741GE5, 00000152737GE3, 00000134590GE9, 00000119522GE1, 00000119523GE9, 00000146655GE6, 00000146668GE9, 00000146669GE7, 00000119519GE7, 00000145765GE4, 00000152738GE1, 00000121182GE0, 00000122793GE3, 00000119517GE1, 00000139086GE3, 00000141801GE1, 00000141802GE9, 00000141803GE7, 00000141804GE5, 00000141805GE2, 00000119521GE3, 00000118133GE8, 00000118134GE6, 00000118135GE3, 00000121180GE4, 00000141807GE8, 00000119516GE3, 00000123926GE8, 00000123931GE8, 00000122794GE1, 00000127524GE7, 00000127525GE4, 00000129247GE3, 00000134588GE3, 00000123927GE6, 00000123929GE2, 00000119520GE5, 00000122797GE4, 00000122795GE8, 00000123930GE0, 00000127522GE1, 00000127523GE9, 00000129243GE2, 00000127520GE5, 00000127521GE3, 00000127526GE2, 00000139088GE9, 00000129246GE5, 00000145645GE8, 00000141808GE6, 00000141811GE0, 00000151783GE8, 100995344, 00000145642GE5, 00000145647GE4, 00000118132GE0, 00000122799GE0, 00000122800GE6, 00000123928GE4, 00000127519GE7, 00000152735GE7, 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Products Sold
Serial Numbers: 00000152741GE5, 00000152737GE3, 00000134590GE9, 00000119522GE1, 00000119523GE9, 00000146655GE6, 00000146668GE9, 00000146669GE7, 00000119519GE7, 00000145765GE4, 00000152738GE1, 00000121182GE0, 00000122793GE3, 00000119517GE1, 00000139086GE3, 00000141801GE1, 00000141802GE9, 00000141803GE7, 00000141804GE5, 00000141805GE2, 00000119521GE3, 00000118133GE8, 00000118134GE6, 00000118135GE3, 00000121180GE4, 00000141807GE8, 00000119516GE3, 00000123926GE8, 00000123931GE8, 00000122794GE1, 00000127524GE7, 00000127525GE4, 00000129247GE3, 00000134588GE3, 00000123927GE6, 00000123929GE2, 00000119520GE5, 00000122797GE4, 00000122795GE8, 00000123930GE0, 00000127522GE1, 00000127523GE9, 00000129243GE2, 00000127520GE5, 00000127521GE3, 00000127526GE2, 00000139088GE9, 00000129246GE5, 00000145645GE8, 00000141808GE6, 00000141811GE0, 00000151783GE8, 100995344, 00000145642GE5, 00000145647GE4, 00000118132GE0, 00000122799GE0, 00000122800GE6, 00000123928GE4, 00000127519GE7, 00000152735GE7, 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GE Medical Systems, LLC is recalling GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image analysis soft due to 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,. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CT, FL, HI, IL, IA, MA, MI, NJ, NY, NC, OK, PA, TX, WA, WV, WI, DC, PR
Page updated: Jan 10, 2026