Z-0669-2010

LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used with 5129909, 5129909-5, and 5129909-11...

Name: Z-0669-2010 LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used with 5129909, 5129909-5, and 5129909-11...
Creator: Ge Healthcare
Published: 2009-10-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-10-01 / Terminated

FDA source

Ge Healthcare began a recall of LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used with 5129909, 5129909-5, and 5129909-11 gantry. For head, whole body, cardiac and vascular... on 2009-10-01. The reason FDA records is "Failure to properly document the CTDI in the Technical Reference or User Manual". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0669-2010
Status: Terminated
Initiated: 2009-10-01
Posted: 2010-02-02
Terminated: 2011-12-10
Recalling firm: GE Healthcare
Product: LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used with 5129909, 5129909-5, and 5129909-11 gantry. For head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Failure to properly document the CTDI in the Technical Reference or User Manual.
FDA root cause: Radiation Control for Health and Safety Act
Action: GE is sending an Important Electronic Product Radiation Warning letter to customers. The letter will describe the defect, identify the affected product details, provide instructions, state the product correction, and the necessary contact information.
Quantity in commerce: 111 units total
Distribution: Nationwide Distribution -- Including states of CT, SD, VA, WA, MA, PA, GA, IL, CA, MD, NY, NC, SC, AZ, TX, MT, FL, OH, OK, MI, CO, ME, WV, TN, KS, and WI.
Product codes and lots: Serial numbers associated with the mentioned Gantry model numbers manufactured from May 2009 to November 2009.

Product code JAK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)