Terminated

Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These system can be operated in a mobile or fixed site environment.

FDA Recall Z-0393-2011 · Posted 2010-11-16

Recalling FirmGE Healthcare, LLC

Recall StatusTerminated

Product CodeMQB

Date Initiated2009-08-06

Date Terminated2012-05-17

Product Quantity365

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024200INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)Ge Medical Systems, Inc. · 2003-01-16 K993037LCV+ VERSION 2Ge Medical Systems, Inc. · 2000-02-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.