Reported Dec 16, 2015 · Terminated
GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular…
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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 the same axial plane taken at different angles.
- Lot codes and dates
- Mfg Lot or Serial # System IDRMHCTREV
224 of 224 codes
00000439632CN18510990918500000439899CN68311907472300000439913CN58311951173000000441487CN68313064488300000441818CN28313297911500000443068CN2GON-151099000000439432CN6190059CT0600000440338CN2220078CT0400000441574CN1030355CT0700000441779CN6CT441683CN000000443105CN2CT443038CN500000440186CN5E416249CT100000437461CN7519646REVO100000442492CN5E416249CT200000443398CN3905521RCT1441961CN0E416249CTE442082CN4403944RCT1442220CN0604988RCT1442268CN9416864RCT1442573CN2604682RCT1AM13ECY8100000440839CN98242104035000000441053CN68242104034500000441107CN08242105010600000441563CN48242104035900000441930CN58242104034600000442030CN38242112047900000442196CN28242103019900000442749CN88242104036900000443203CN58242130007200000443282CN9
441520CN4203688ERREV1441553cn5215952CTREV441647CN5847437ACT7441739cn0217876REVO1441916CN4469841REVO442050CN1206598ERREV442300CN0281274REV442376CN0262574REVO442719cN1727398REVO512DELLCT205699CTREVAM13NAY127
- Mfg Lot or Serial # System ID
- Amount recalled
- 125 (US = 37; OUS = 88)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new GE Medical Systems, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.