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Terminated

Innova 2000, manufactured by GE Medical Systems, SCS

FDA Recall Z-2238-2010 · Posted 2010-08-19

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMQB
Date Initiated2010-06-10
Date Terminated2014-04-01
Product Quantity885

Reason for Recall

A hardware component (potentiometer and encoder)mismatch in Innova 2000 digital fluoroscopic imaging systems may cause a Source to Image Distance (SID) failure, which will cause the imager to fail to detect the distance between the imager and the patient. This will result in loss of the x-ray image if the recovery process is not performed. The error message to use the Emergency Back-Out Button for

Firm Action

GE Healthcare sent a GE "Urgent Medical Device Correction" dated June 9, 2010letter to consignees. The letter was addressed to Hospital Administrators / Risk Mangers; Mangers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details; Safety Instruction; Product Correction and Contact Information. The letter detailed the method for identifying SID failure and the use of the emergency back-out buttoms to recover the X-ray image. A GE service representative will affix a label to the device on-site to remind operators how to recover from loss of X-ray from SID failure. Consignees may contact GE at 800 437-1171, option 4.

Root Cause

Other

Distribution Pattern

Worldwide distribution: States of AL, AZ, AR, CA, CO, CT,DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV,NH, NJ, NM, NH,NC, ND, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, and WI, and countries of VENEZUELA, UNITED KINGDOM, TURKEY, TUNISIA, THAILAND, TAIWAN, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, POLAND, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MARTINIQUE, LITHUANIA, LEBANON, JORDAN, JAPAN, ITALY, ISRAEL, ISLAMIC REPUBLIC OF IRAN, IRELAND, INDONESIA, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, EGYPT , ECUADOR, COLOMBIA, CHINA, CANADA, BULGARIA, BRAZIL, BELGIUM, BELARUS, AUSTRALIA, and ALGERIA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024200INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)Ge Medical Systems, Inc. · 2003-01-16K022322INNOVA AND INNOVA 2000 SGe Medical Systems, Inc. · 2002-10-08K993037LCV+ 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.

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