| Class 2 Device Recall GE Stenographe |  |
Date Initiated by Firm | July 01, 2008 |
Date Posted | September 26, 2008 |
Recall Status1 |
Terminated 3 on December 11, 2011 |
Recall Number | Z-2147-2008 |
Recall Event ID |
49509 |
510(K)Number | K941191 K990066 |
Product Classification |
Mammographic X-Ray system - Product Code IZH
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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. |
Code Information |
model 2405544-3, Serial numbers: 00000509762BU1, 00000509764BU7, 00000543767BU8, 00000546136BU3, 00000546140BU5, 00000546772BU5, 00000546793BU1, 00000546794BU9, 00000546799BU8, 00000550251BU3, 00000550265BU3, and 00000550266BU1. |
Recalling Firm/ Manufacturer |
GE Healthcare 3000 N Grandview Blvd Waukesha WI 53188-1615
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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 |
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 | 12 |
Distribution | AL, CA, CO, FL, IL, KS, MA, ME, MN,MO, NC, NJ, NM, NY OK, SC, TN, TX, and WI. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = IZH 510(K)s with Product Code = IZH
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