Z-1257-2009

GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT...

Name: Z-1257-2009 GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT...
Creator: GE Medical Systems, LLC
Published: 2009-03-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-03-12 / Terminated / root cause: labeling and UDI

FDA source

GE Medical Systems, LLC began a recall of GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems on 2009-03-12. The reason FDA records is "Failure to provide the certification label required by 21 CFR 1010.2". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1257-2009
Status: Terminated
Initiated: 2009-03-12
Posted: 2009-09-25
Terminated: 2011-12-10
Recalling firm: GE Healthcare
Product: GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Failure to provide the certification label required by 21 CFR 1010.2.
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: A GE Field Service Representative will visit each affected customer site and affix the certification label required. A Field Modification Instruction (FMI Number 25412) has been developed for release to all facilities in possession of the affected systems.
Quantity in commerce: 1179 total of all units
Distribution: Nationwide Distribution
Product codes and lots: All tables and serial numbers associated wtih Model Number 2225283.

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)