Z-0286-2011

BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole body X-ray Computed...

Name: Z-0286-2011 BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole body X-ray Computed...
Creator: GE Healthcare, LLC
Published: 2010-05-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2010-05-01 / Terminated

FDA source

GE Healthcare, LLC began a recall of BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole body X-ray Computed Tomography applications on 2010-05-01. 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-0286-2011
Status: Terminated
Initiated: 2010-05-01
Posted: 2011-03-01
Terminated: 2013-12-05
Recalling firm: GE Healthcare
Product: BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole body 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: Planned action(s) to repair defect or to bring product into compliance: GE Healthcare will bring the Technical Reference Manual into compliance by correcting the noncompliance in forward production and the installed base units. This will be accomplished by delivering an "Important Electronic Product Radiation Warning" letter and a TRM addendum which contains the corrected information to customers. This will be carried out via a Field Modification Instruction IFMI 229251 planned to be released in October, 2010 with an estimated completion date of April, 2011. The letter identifies the affected product and describes the defect and related hazards. It also asks customers to refer to the TRM addendum for the scan time accuracy, the helical scan exposure time, and the CTDI adjustment factors for 4 and 8 slices. Contact information is also provided.
Quantity in commerce: 103 units
Distribution: Nationwide Distribution
Product codes and lots: Gantry model numbers 5191001, 5191002, 5191003, and 5191003-2.

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)