Z-0368-2011

GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of a gantry, patient...

Name: Z-0368-2011 GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of a gantry, patient...
Creator: GE Healthcare, LLC
Published: 2010-09-03
License: https://open.fda.gov/license/

GE Healthcare / initiated 2010-09-03 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of a gantry, patient table, operator console, computer, and PDU and... on 2010-09-03. The reason FDA records is "GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0368-2011
Status: Terminated
Initiated: 2010-09-03
Posted: 2010-11-15
Terminated: 2012-05-15
Recalling firm: GE Healthcare
Product: GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 USA. Is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Medical Device Correction letter dated September 2, 2010 was sent to consignees beginning September 3, 2010. This letter addressed the LightSpeed VCT systems. Another Urgent Medical Device Correction letter, dated September 24, 2010 was sent September 24, 2010 for the BrightSpeed Systems. The letters described the issue and provided safety instructions for the health care provider to be aware if the table should stop unexpectedly and the x-ray remains on to manually stop the scan until the devices software is upgraded. If you have any questions, please contact the US (800) 437-1171, Japan 0120-055-919, Korea 1544-6119, Australia/New Zealand 800 659 465, China 800-810-8188; for other countries, please contact your local GE Healthcare Services Representative.
Quantity in commerce: 68
Distribution: Worldwide distribution: USA including states of: MI, NM, OH, TX, and Puerto Rico and countries including: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Ireland, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Kenya, Lebanon, Malaysia, Mauritania, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Pakistan, Paraguay, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Togo, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Viet Nam.
Product codes and lots: Model 5212920-300, serial numbers: 00000021775YC2. 00000408285CN5. 00000409136CN9. 00000412029CN1. 00000412391CN5. 00000414803CN7. 00000415599CN0. 00000416813CN4. 00000417885CN1. Model 5212920-310, serial numbers: 00000416740CN9. 00000417311CN8. 00000417519CN6. 00000417884CN4. 00000417886CN9. 00000417916CN4. 00000417917CN2. 00000417918CN0. 00000417919CN8. 00000417925CN5. 00000417926CN3. 00000417989CN1. 00000417990CN9. 00000418000CN6. 00000418055CN0. 00000418056CN8. 00000418057CN6. 00000418058CN4. 00000418059CN2. 00000418060CN0. 00000418062CN6. 00000418063CN4. 00000418064CN2. 00000418065CN9. 00000418126CN9. 00000418141CN8. 00000418142CN6. 00000418179CN8. 00000418218CN4. 00000418219CN2. 00000418220CN0. 00000418221CN8. 00000418222CN6. 00000418246CN5. 00000418260CN6. 00000418261CN4. 00000418266CN3. 00000418272CN1. 00000418293CN7. 00000418296CN0. 00000418337CN2. 00000418355CN4. 00000418365CN3. 00000418400CN8. 00000418404CN0. 00000418467CN7. 00000418541CN9. 00000418542CN7. 00000418581CN5. 00000418586CN4. 00000418604CN5. 00000418706CN8. 00000418717CN5. 00000418789CN4. 00000418790CN2. 00000418793CN6. Model 5311595-10, serial numbers: 00000031546CO5. 00000031835CO2. 00000031838CO6.

Product code JAK

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)