Innova 2000…

Date posted by the FDA

Aug. 19, 2010

Status

Terminated

Filed by

GE Healthcare, LLC

Product

Innova 2000, manufactured by GE Medical Systems, SCS

Reason

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

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.

Quantity

885

Codes and lots

Serial Number 00000407955BU4 00000068492VE8 00000418005BU5 00000393455BU1 00000397050BU6 00000350519BU5 00000079547VE6 00000378676BU1 00000099732VEO 00000079541VE9 00000341536BU1 00000347472BU3 00000338024BU3 00000341530BU4 00000348536BU4 00000422097BU6 00000423545BU3 00000385319BU9 00000409300BU1 00000389501BU8 00000383125BU2 00000423003BU3 00000415056BU1 00000420520BU9 00000379761BU0 00000418004BU8 00000377024BU5 00000419716BU6 00000400569BU0 00000386267BU9 00000068497VE7 00000423644BU4 00000423322BU7 00000405271BU8 00000099736VE1 00000099734VE6 00000079533VE6 00000392274BU7 00000343649BU0 00000400526BU0 00000354849BU2 00000404101BU8 00000399595BU8 00000336869BU3 00000337306BU5 00000338357BU7 00000392563BU3 00000068487VE8 00000074875VE6 00000074883VE0 00000351997BU2 00000422239BU4 00000403685BU1 00000403431BU0 00000393733BU1 00000074904VE4 00000341095BU8 00000396197BU6 00000382877BU9 00000420841BU9 00000015656VE2 00000382939BU7 00000415705BU3 00000351549BU1 00000359555BU0 00000407957BU0 00000342077BU5 00000068495VE1 00000347111BU7 00000333743BU3 00000372500BU9 00000387489BU8 00000418299BU4 00000351996BU4 00000338356BU9 00000393646BU5 00000347468BU1 00000347468BU1 00000354203BU2 00000424046BU1 00000399750BU9 00000087032VE9 00000351552BU5 00000395215BU7 00000345249BU7 00000344212BU6 00000404675BU1 00000405835BU0 00000019854VE9 00000409880BU2 00000419653BU1 00000104763VE8 00000407956BU2 00000397405BU2 00000384311BU7 00000402924BU5 00000074886VE3 00000413029BU0 00000419167BU2 00000039470VE0 00000087013VE9 00000400646BU6 00000025817VE8 00000342699BU6 00000104774VE5 00000104755VE4 00000422426BU7 00000395214BU0 00000397053BU0 00000361744BU6 00000019863VE0 00000074900VE2 00000392773BU8 00000386173BU9 00000388900BU3 00000407950BU5 00000408333BU3 00000382096BU6 00000104767VE9 00000389097BU7 00000389796BU4 00000389994BU5 00000397644BU6 00000397643BU8 00000099718VE9 00000074891VE3 00000386307BU3 00000332678BU2 00000385405BU6 00000394210BU9 00000104761VE2 00000099738VE7 00000368115BU2 00000383992BU5 00000367496BU7 00000350866BU0 00000421317BU9 00000099710VE6 00000380627BU0 00000424693BU0 00000055062VE4 00000399939BU8 00000392732BU4 00000400805BU8 00000376219BU2 00000424660BU9 00000068477VE9 00000104769VE5 00000416123BU8 00000408600BU5 00000074905VE1 00000354204BU0 00000337504BU5 00000083311VE1 00000074899VE6 00000087017VE0 00000104756VE1 00000416885BU2 00000338640BU6 00000411170BU4 00000401024BU5 00000414823BU5 00000394212BU5 00000341749BU0 00000421580BU2 00000373282BU3 00000099729VE6 00000087014VE7 00000432743BU3 00000426713BU4 UNK2243594-300 00000423873BU9 00000411171BU2 00000404677BU7 00000407657BU6 00000406023BU2 00000366246BU7 00000406108BU1 00000392245BU7 00000375409BU0 00000381436BU5 00000374480BU2 00000385830BU5 00000426880BU1 00000409162BU5 00000392766BU2 00000440232BU7 00000440085BU9 00000381846BU5 00000347473BU1 00000083310VE3 00000079544VE3 00000393731BU5 00000026257VE6 00000421196BU7 00000343038BU6 00000346258BU7 00000386952BU6 00000346261BU1…

Recall started

June 10, 2010

Device type

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Root cause (FDA)

Other

What the company told customers

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.

Recall number

Z-2238-2010

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2238-2010. The agency record governs; check it and the company before acting.