GE Healthcare 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
GE Healthcare
Lot Codes / Batch Numbers
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.
Products Sold
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.
GE Healthcare is recalling GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field Mammography system due to 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 performe. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, CO, FL, IL, KS, ME, MA, MN, MO, NJ, NM, NY, NC, OK, SC, TN, TX, WI
Page updated: Jan 10, 2026