GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from t
Check against the official notice below — it lists the full affected range.
GE Healthcare has identified a potential issue affecting Revolution CT scanners used for head scans. During routine head scans, artifacts may appear in images between brain tissue and bone that could resemble pathology or disease. The affected scanners are distributed worldwide, including across the United States and multiple international locations. A total of 125 units are involved in this recall, and no injuries have been reported related to this issue.
The recall affects specific Revolution CT scanner models identified by their serial numbers and system IDs. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue.
Reason for recall: GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue. Distribution: Worldwide Distribution: US (nationwide) including states of: AL, CA, CT, FL, GA, HI, IL, NY, NC, OH, OR, PA, TX, UT, VA, WA, WI; and countries of: AUSTRALIA, BELGIUM BRAZIL, CANADA, CHINA,DENMARK, FRANCE, GERMANY, HONG KONG, INDONESIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, NORWAY, PERU, POLAND, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM. Quantity: 125 (US = 37; OUS = 88) Lot/code info: Mfg Lot or Serial # System ID 00000439632CN1 85109909185 00000439899CN6 83119074723 00000439913CN5 83119511730 00000441487CN6 83130644883 00000441818CN2 83132979115 00000443068CN2 GON-1510990 00000439432CN6 190059CT06 00000440338CN2 220078CT04 00000441574CN1 030355CT07 00000441779CN6 CT441683CN0 00000443105CN2 CT443038CN5 00000440186CN5 E416249CT1 00000437461CN7 519646REVO1 00000442492CN5 E416249CT2 00000443398CN3 905521RCT1 441961CN0 E416249CTE 442082CN4 403944RCT1 442220CN0 604988RCT1 442268CN9 416864RCT1 442573CN2 604682RCT1 AM13ECY81 00000440839CN9 82421040350 00000441053CN6 82421040345 00000441107CN0 82421050106 00000441563CN4 82421040359 00000441930CN5 82421040346 00000442030CN3 82421120479 00000442196CN2 82421030199 00000442749CN8 82421040369 00000443203CN5 82421300072 00000443282CN9 82421190317 00000443322CN3 82421120484 00000443348CN8 82421040370 442794CN4 GON-1510879 00000442517CN9 DK1051CT04 00000437837CN8 M2322254 00000440172CN5 P4192906 00000441238CN3 X41944012 00000441687CN1 M2800929 00000441895CN0 M41980112 00000442351CN3 E4191734 00000442588CN0 M44827197 00000442845CN4 M5480791 00000439243CN7 PC3383CT01 00000441264CN9 HC5284CT04 00000438342CN8 828210096 00000440967CN8 835210259 00000442981CN7 5973CT0019 00000439938CN2 A5624142 00000437028CN4 REV001 00000439356CN7 REV006 00000439639CN6 REV003 00000439802CN0 REV002 00000439812CN9 REV004 00000440092CN5 REV008 00000440113CN9 REV005 00000440682CN3 REV007 00000441280CN5 REV009 00000441460CN3 REV011 00000442008CN9 RE
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.