FDA Medical Device Recalls (openFDA)
GE Healthcare: GE Stereotaxy Positioner, model 2405544-3, 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 number
- Z-2147-2008
- Recalling firm
- GE Healthcare
- Product
- GE Stereotaxy Positioner, model 2405544-3, 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.
- Status
- Terminated
- Initiated
- 2008-07-01
- Posted
- 2008-09-26
- Terminated
- 2011-12-11
- Reason
- 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
- 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
- 12
- Distribution
- AL, CA, CO, FL, IL, KS, MA, ME, MN,MO, NC, NJ, NM, NY OK, SC, TN, TX, and WI.
- Lot, serial or model codes
- model 2405544-3, Serial numbers: 00000509762BU1, 00000509764BU7, 00000543767BU8, 00000546136BU3, 00000546140BU5, 00000546772BU5, 00000546793BU1, 00000546794BU9, 00000546799BU8, 00000550251BU3, 00000550265BU3, and 00000550266BU1.
- 510(k) numbers
- ["K941191","K990066"]
- PMA numbers
- not on file
- Product code
- IZH
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28