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U.S. Department of Health and Human Services

Class 2 Device Recall GE Precision MPi

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  Class 2 Device Recall GE Precision MPi see related information
Date Initiated by Firm July 01, 2008
Date Posted February 24, 2016
Recall Status1 Terminated 3 on July 11, 2017
Recall Number Z-0753-2016
Recall Event ID 72515
510(K)Number K033486  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
Code Information NRT no.: 02980000
Recalling Firm/
Manufacturer		 Regulatory Insight, Inc
33 Golden Eagle Ln
Littleton CO 80127-5745
Manufacturer Reason
for Recall		 It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Nordisk Rontgen Teknik ( NRT ) Planned action to bring defect into compliance: 1.Nordisk Rontgen Teknik A/S (NRT) will contact customers and initiate a software and hardware update to correct the defect. 2.NRT engineers will install the software and perform testing to ensure the software and hardware update was effective. 3.The customer notification letter which includes a statement that NRT will without charge, remedy the defect or bring the product into compliance. For further questions please call (720) 962- 5412.
Quantity in Commerce 43
Distribution US Distribution to the states of :TN, CA, WA, OR, PA, WI, FL, MN, VT, NY, NV, MA, CO, IN, MI, MS and OH.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OWB and Original Applicant = NRT-NORDISK RONTGEN TEKNIK A/S
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