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U.S. Department of Health and Human Services

Class 2 Device Recall GE Stenographe

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 Class 2 Device Recall GE Stenographesee related information
Date Initiated by FirmJuly 01, 2008
Date PostedSeptember 26, 2008
Recall Status1 Terminated 3 on December 11, 2011
Recall NumberZ-2146-2008
Recall Event ID 49509
510(K)NumberK941191 K990066 
Product Classification Mammographic X-Ray system - Product Code IZH
ProductGE 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.
Code Information 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.
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer 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 Determined
Cause 2		Radiation Control for Health and Safety Act
ActionA 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 Commerce27
DistributionAL, CA, CO, FL, IL, KS, MA, ME, MN,MO, NC, NJ, NM, NY OK, SC, TN, TX, and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IZH
510(K)s with Product Code = IZH
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