Z-0805-2007

GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems

Name: Z-0805-2007 GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems
Creator: GE Healthcare
Published: 2006-12-21
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-12-21 / Terminated

FDA source

GE Healthcare began a recall of GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems on 2006-12-21. The reason FDA records is "Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0805-2007
Status: Terminated
Initiated: 2006-12-21
Posted: 2007-05-15
Terminated: 2012-07-03
Recalling firm: GE Healthcare
Product: GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.
FDA root cause: Other
Action: A Field Modification Instruction was issued to the field to inspect all systems and replace the tube window screws and the window filter, as well as clean any traces of oil in the tube window area. A 12/21/2006, Urgent Product Correction Notice/Customer letter has also been distributed informing the customers of the safety issue and the product correction.
Quantity in commerce: 21
Distribution: Worldwide Distribution: USA in the following states and locations: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, Guam and Puerto Rico. Foreign countries include ; Albania, Algeria, Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Canada, Chile, China, Columbia, Czechoslovakia, Denmark, Finland, France, Germany, Great Britain, Greece, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Reunion Island, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Venezuela, and Vietnam
Product codes and lots: All serial numbers

Product code JAK

K060052Class IIGe Lightspeed Xtra CT Scanner SystemGe Medical Systems, LLC / cleared 2006-04-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)