Z-0768-2011

HiSpeed DX/I (2249696)

Name: Z-0768-2011 HiSpeed DX/I (2249696)
Creator: GE Healthcare, LLC
Published: 2010-02-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2010-02-01 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of HiSpeed DX/I (2249696) on 2010-02-01. The reason FDA records is "A defect with the hardware and software displaying the incorrect dose data". 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-0768-2011
Status: Terminated
Initiated: 2010-02-01
Posted: 2011-01-04
Terminated: 2014-05-21
Recalling firm: GE Healthcare
Product: HiSpeed DX/I (2249696)
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: A defect with the hardware and software displaying the incorrect dose data.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Quantity in commerce: 102 total
Distribution: Nationwide Distribution
Product codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.

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)