| Class 2 Device Recall Digital Fluoroscopic Imaging System | |
Date Initiated by Firm | June 24, 2008 |
Date Posted | September 21, 2008 |
Recall Status1 |
Terminated 3 on December 17, 2011 |
Recall Number | Z-2360-2008 |
Recall Event ID |
48961 |
510(K)Number | K061163 |
Product Classification |
Fluoroscopic X-ray system - Product Code MQB
|
Product | Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment. |
Code Information |
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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 become aware of 2 potential conditions that could occur with the MAVIG GD Monitor Suspension that is used with Advantx-E, Innova 2000, 21000IQ, 3100/3100IQ, 4100/4100IQ and 2121 IQ/3131IQ cardiovascular systems.
The two conditions include 1). Due to insufficient securing of the connecting elements, the LCD vertical monitor support may disengage from its arm and fall on the tab |
FDA Determined Cause 2 | Employee error |
Action | The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance. |
Quantity in Commerce | 26 + 537 (system not installed therefore product not stated) |
Distribution | USA:
AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN
TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI
OUS:
ALGERIA
AUSTRALIA
AUSTRIA
BELARUS
BELGIUM
BRASIL
CANADA
CHILE
CHINA
CHINA
COLUMBIA
CZECH REPUBLIC
DENMARK
DV
EGYPT
FINLAND
FRANCE
GEORGIA
GERMANY
GREECE
GUATAMALA
HONG KONG
HUNGARY
INDIA
INDONESIA
IRAN
IRAQ
IRELAND
ISRAEL
ITALY
JAPAN
KOREA
KUWAIT
LATVIA
LEBANON
MACEDONIA
MALAYSIA
MEXICO
MOROCCO
NETHERLANDS
NEW ZEALAND
NORWAY
PAKISTAN
PANAMA
POLAND
PORTUGAL
PUERTO RICO
RUSSIA
SAUDI ARABIA
SINGAPORE
SLOVAKIA
SPAIN
SUDAN
SWEDEN
SWITZERLAND
SYRIA
TAIWAN
TUNISIA
TURKEY
UNITED ARAB EMIRATES
UNITED KINGDOM and
VENEZUELA |
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 = MQB
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