Z-0507-2007

The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications

Name: Z-0507-2007 The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications
Creator: GE Healthcare
Published: 2006-12-08
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-12-08 / Terminated

FDA source

GE Healthcare began a recall of The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications on 2006-12-08. The reason FDA records is "When the manual cradle release feature on the table is used to move a patient out of the gantry, a discrepancy of up to 6mm between the numerical display on the gantry and the actual position of the table could be...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0507-2007
Status: Terminated
Initiated: 2006-12-08
Posted: 2007-02-15
Terminated: 2007-11-30
Recalling firm: GE Healthcare
Product: The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: When the manual cradle release feature on the table is used to move a patient out of the gantry, a discrepancy of up to 6mm between the numerical display on the gantry and the actual position of the table could be introduced.
FDA root cause: Other
Action: A Product Safety Advisory Notice, dated December 8, 2006, was issued to all customers informing them of the safety issue and production correction. Customers are advised to operate the CT cradle as intended with the system''s electronic controls. If a critical need arises to release the cradle during a radiation therapy simulation scan, they are advised to independently verify patient position prior to marking the patient for therapy to avoid the potential inaccuracy. A software update will be installed to correct this problem by a GE representative.
Quantity in commerce: 1,256 units
Distribution: Worldwide, including USA, Puerto Rico, Albania, Argentina, Austria, Australia, Belarus, Belgium, Bulgaria, Brazil, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Great Britain, Greece, Guam, Hong Kong, Honduras, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia , Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Reunion Island, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain , Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Venezuela, Vietnam, and Yugoslavia.
Product codes and lots: All serial numbers

Product code JAK

K040372Class IILightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC / cleared 2004-03-01

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)