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Class 2 Device Recall Proteus XR/a |
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Date Initiated by Firm |
August 09, 2019 |
Date Posted |
September 20, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2449-2019 |
Recall Event ID |
83647 |
510(K)Number |
K993090
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Product Classification |
System, x-ray, stationary - Product Code KPR
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Product |
Proteus XR/a (SlOK : K993090) |
Code Information |
console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H) |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact |
800-437-1171
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Manufacturer Reason for Recall |
Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
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FDA Determined Cause 2 |
Device Design |
Action |
GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. A GE Healthcare representative will contact you to arrange for the correction .
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1- 800-437-1171or your local Service Representative. |
Quantity in Commerce |
647 US; 167 OUS |
Distribution |
Worldwide - US Nationwide |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = KPR and Original Applicant = GE MEDICAL SYSTEMS, INC.
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