Z-0007-2011

HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected...

Name: Z-0007-2011 HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected...
Creator: GE Medical Systems, LLC
Published: 2009-05-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-05-01 / Terminated / root cause: labeling and UDI

FDA source

GE Medical Systems, LLC began a recall of HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole... on 2009-05-01. The reason FDA records is "It was discovered that the operator console did not have a label affixed in accordance with 21CFR 1010.2 indicating certification to applicable performance standards". 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-0007-2011
Status: Terminated
Initiated: 2009-05-01
Posted: 2010-12-17
Terminated: 2012-05-16
Recalling firm: GE Healthcare
Product: HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: It was discovered that the operator console did not have a label affixed in accordance with 21CFR 1010.2 indicating certification to applicable performance standards.
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: GE Healthcare will bring customer systems into compliance with 21 CFR by having a GE Healthcare field service representative, who will perform a field corrective action, visit each customer site. This will be carried out via a Field Modification Instruction planned to be released in October 2009 and planned to be completed by February 2010. Additionally, all forward production operator consoles are manufactured so as to comply with 21 CFR and to include a manufacturing check for appropriate labeling.
Quantity in commerce: 45 units (13 Nationwide)
Distribution: Worldwide Distribution -- USA, including states of ME, FL, IA, AL, CT, CA, TX, KS, KY, OH, and WV and countries of Japan, Russian Federation, India, Argentina, Brazil, Italy, Poland, Puerto Rico, Romania, and Saudi Arabia.
Product codes and lots: Console Serial Numbers: 074639HM6, 659297YM6, 695155YM2, 730392YM8, 777756YM8, 789223YM5, 818161YM2, 836965YM4, 836971YM2, 864568YM 1, 869641 YM 1, 530941YM4, 594144YM8, 659292YM7, 678189YM2, 65931 1YM5, 696890YM3, 530873YM9, 659208YM3, 730349YM8, 544504YM4, 766560YM7, 766630YM8, 856398YM3, 474793YM7, 530946YM3, 874664YM6, 813279YM7, 839995YM8, 854095YM7, 869512YM4, 766587YMO, 887561YM9, 840000YM4, 813261 YM5, 717723YM1, 717727YM2, 877979YM5, 808479YMO, 812782YM1, 659200YMO, 766610OYMO, 877971YM2, 730393YM6, and 865531YM8.

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)