Z-0495-2010

Infinia with Hawkeye 4, model numbers: H3000WC and H3000WD. GE Healthcare, Waukesha, Wisconsin 53118...

Name: Z-0495-2010 Infinia with Hawkeye 4, model numbers: H3000WC and H3000WD. GE Healthcare, Waukesha, Wisconsin 53118...
Creator: GE Medical Systems, LLC
Published: 2009-08-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-08-01 / Terminated

FDA source

GE Medical Systems, LLC began a recall of Infinia with Hawkeye 4, model numbers: H3000WC and H3000WD. GE Healthcare, Waukesha, Wisconsin 53118. Generating head and whole body CT images of human subjects on 2009-08-01. The reason FDA records is "Failure to provide the complete User Manual information". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0495-2010
Status: Terminated
Initiated: 2009-08-01
Posted: 2010-01-21
Terminated: 2012-02-04
Recalling firm: GE Healthcare
Product: Infinia with Hawkeye 4, model numbers: H3000WC and H3000WD. GE Healthcare, Waukesha, Wisconsin 53118. Generating head and whole body CT images of human subjects
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Failure to provide the complete User Manual information.
FDA root cause: Radiation Control for Health and Safety Act
Action: A Field Modification Instruction will be released in February 2010. GE Healthcare will correct the Operator Manuals in forward production and the installed base units.
Quantity in commerce: 343 total
Distribution: Nationwide Distribution
Product codes and lots: All serial numbers associated with model numbers H3000WC and H3000WD.

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)