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U.S. Department of Health and Human Services

Class 2 Device Recall Celex/GE Precision MPi

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  Class 2 Device Recall Celex/GE Precision MPi see related information
Date Initiated by Firm May 01, 2009
Date Posted September 29, 2009
Recall Status1 Terminated 3 on October 20, 2009
Recall Number Z-1658-2009
Recall Event ID 52173
510(K)Number K033486  
Product Classification Image-Intensified Fluoroscopic X-Ray System - Product Code JAA
Product Celex/GE Precision MPi, REF no.: 02980000

Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
Code Information Serial Numbers: 507003, 507004, 507005, 510004, 510009, 510010, 513001, 513003, 513007, 518001, 518002, 518004, 518005, 518006, 518011, 518013, 518014, 518015, 518017, 518018, 518020, 522001, 522002, 522003, 522004, 522005, 522006, 522008, 522009, 522012, 522014, 522015, 522016, 522018, 522019, 536001, 536002, 536003, 536006 and 536007.
Recalling Firm/
Manufacturer		 NRT - Nordisk Rontgen Teknik A/S
Birkegaardsvej 16
Hasselager Denmark
For Additional Information Contact Kevin Walls
720-962-5412
Manufacturer Reason
for Recall		 The GE Precision MPi is in violation with 21 CFR Part 1020.32 requiring a signal audible to the fluoroscopist to sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action An Advisory Notice concerning GE Precision MPi, dated May 1, 2009, was issued to Healthcare Professionals. The notice discussed the problem, risk, recommended immediate action, future actio, and affected system and serial numbers. A GE Field Service Representative will visit each affected U.S. customer site and introduce a speaker connected to the generator touch screen (to which the audible tone is delivered) in the operator's room, to be placed on the wall in the x-ray room. For further information, customers were to contact their local GE field engineer.
Quantity in Commerce 38 units (US)
Distribution Nationwide Distribution, including CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OR, PA, TN, VT, WA, WI.
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 = JAA and Original Applicant = NRT-NORDISK RONTGEN TEKNIK A/S
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