Z-2146-2008

GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field Mammography system, models...

Name: Z-2146-2008 GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field Mammography system, models...
Creator: GE Healthcare
Published: 2008-07-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-07-01 / Terminated

FDA source

GE Healthcare began a recall of GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1... on 2008-07-01. The reason FDA records is "GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use of the Stereotactic...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2146-2008
Status: Terminated
Initiated: 2008-07-01
Posted: 2008-09-26
Terminated: 2011-12-11
Recalling firm: GE Healthcare
Product: GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senographe DS Stereotaxy is an optional accessory for the Senographe system for mammography examinations.
Product code: IZH System, X-Ray, Mammographic
Reason for recall: GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use of the Stereotactic Positioner of your Senographe DS Acquisition system and could impact patient safety. If the Stereotactic Positioner is removed when the examination arm is at 33 degrees and, th
FDA root cause: Radiation Control for Health and Safety Act
Action: A Product Safety Notification letter, dated March 3, 2008, was sent to affected customers. The letter provided information about the safety issue, identified affected product and stated that GE Healthcare will provide a software upgrade. Contact GE Healthcare at 1-262-544-3894 for assistance.
Quantity in commerce: 27
Distribution: AL, CA, CO, FL, IL, KS, MA, ME, MN,MO, NC, NJ, NM, NY OK, SC, TN, TX, and WI.
Product codes and lots: model 2405544-2, serial numbers: 00000434834BU8, 00000434837BU1, 00000437358BU5, 00000437363BU5, 00000437366BU8, 00000437366BU8, 00000444593BU8, 00000444603BU5, 00000450276BU1, 00000450289BU4, 00000454195BU9, 00000454197BU5, 00000454200BU7, 00000454202BU3, 0000046417BU0, 00000464622BU0, 00000464628BU7, 00000484259BU7, 00000484270BU4, 00000484290BU2, 00000484297BU7, 0000048429BU4, 00000492966BU7, 00000492975BU8, 00000494921BU0, 00000500104BU5, and 00000500118BU5.

Product code IZH

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)