—#73696

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.

FDA product code: IZH — System, X-Ray, Mammographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K941191, K990066
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: GE Healthcare
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: AL, CA, CO, FL, IL, KS, MA, ME, MN,MO, NC, NJ, NM, NY OK, SC, TN, TX, and WI.

Timeline

Recall initiated: 2008-07-01
Posted by FDA: 2008-09-26
Terminated: 2011-12-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73696. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.