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U.S. Department of Health and Human Services

Class 2 Device Recall Innova 4100

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  Class 2 Device Recall Innova 4100 see related information
Date Initiated by Firm August 06, 2009
Date Posted November 16, 2010
Recall Status1 Terminated 3 on May 17, 2012
Recall Number Z-0392-2011
Recall Event ID 56988
510(K)Number K023178  K993037  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.
Code Information 00000419171BU4 00000410733BU0 00000421241BU1 00000410864BU3 00000416634BU4 00000411063BU1 00000417936BU2 00000409754BU9 00000416591BU6 00000415816BU8 00000420529BU0 00000415698BU0 00000421391BU4 00000416641BU9 00000409937BU0 00000416642BU7 00000415575BU9 00000420851BU8 00000416960BU3 00000411137BU3 00000408040BU4 00000417375BU3 00000398531BU4 00000417617BU8 00000415776BU4 00000415045BU4 00000403215BU7 00000425774BU7 00000400392BU7 00000418618BU5 00000416643BU5 00000413567BU9 00000415179BU1 00000419079BU9 00000409755BU6 00000412766BU8 00000000LS8-C1 00000425390BU2 00000413716BU2 00000398530BU6 00000405584BU4 00000406451BU5 00000417372BU0 
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		 GE Healthcare has become aware of a potential video splitter failure with certain Innova 2000 and 4100 X-ray systems that may impact patient safety. A potential video splitter failure inside the GE equipment cabinet could occur with no advance warning and thereby prevent x-ray image display. Should this occur, the system cannot be recovered without service intervention. GE Healthcare has obse
FDA Determined
Cause 2		 Nonconforming Material/Component
Action GE Healthcare sent an " Urgent Medical Device Correction" letter dated July 9, 2009, to Hospital Administrators / Risk mangers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter identified the product, described the Safety Issue, Affected Product Details, Safety Instructions Product correction and Contact Information. Hospitals were instructed to establish emergency workflow procedures should a component stop operating during a patient examination. A GE Healthcare service representative would contact each customer and correct all affected systems. For questions regarding this recall call (262) 548-2731.
Quantity in Commerce 43
Distribution Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX UT, VA, WA, WV, and WI, and the countries of UNITED KINGDOM, TUNISIA, TAIWAN, PROVINCE OF CHINA, SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN D=FEDERATION, POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MEXICO, MARTINIQUE, LITHUANIA, LEBANON, REPUBLIC OF KOREA, JORDAN, JAPAN, ITALY, IRELAND, ISLAMIC IRAN, INDONESIA, INDIA, GREECE, GERMANY, FRANCE, FINLAND , EGYPT, CHILE, CANADA, BULGARIA, BELGIUM BELARUS, AUSTRALIA.
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 = MQB and Original Applicant = GE MEDICAL SYSTEMS, INC.
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