FDA · Medical device recall

Innova 4100/4100IQ GE Innova 4100 / 4100 IQ… and 1 more product

Nov. 16, 2010

Date posted by the FDA: Nov. 16, 2010
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: 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
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.

2 products in this recall

Innova 4100/4100IQ GE Innova 4100 / 4100 IQ…

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.
Quantity: 43
Codes and lots: 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
Recall started: Aug. 6, 2009
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Nonconforming Material/Component
What the company told customers: 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.
Recall number: Z-0392-2011

Innova 2000 The principle system components include a C-arm…

Product: 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.
Quantity: 365
Codes and lots: 00000386307BU3 00000416240BU0 00000416671BU6 00000410737BU1 00000394213BU3 00000393185BU4 00000367089BU0 00000358524BU7 00000416632BU8 00000385319BU9 00000407956BU2 00000380196BU6 00000379745BU3 00000408100BU6 00000409042BU9 00000397053BU0 00000346261BU1 00000388459BU0 00000366739BU1 00000395215BU7 00000380627BU0 00000343649BU0 00000392274BU7 00000376219BU2 00000400526BU0 00000415567BU7 00000375036BU1 00000377023BU7 00000340384BU7 00000361277BU7 0000395214BU02 00000403889BU9 00000340373BU0 00000408600BU5 00000394213BU3 00000399595BU8 00000404101BU8 00000419220BU9 00000418004BU8 00000416123BU8 00000427532BU7 00000351550BU9 00000393733BU1 00000411171BU2 00000367495BU9 00000419070BU8 00000382939BU7 00000407088BU4 00000352612BU6 00000378676BU1 00000338024BU3 00000347472BU3 00000382816BU7 00000391288BU8 00000381847BU3 00000354201BU6 00000373281BU5 00000385862BU8 00000408597BU3 00000406234BU5 00000397051BU4 00000416881BU1 00000374925BU6 00000387300BU7 00000358211BU1 00000386952BU6 00000340820BU0 00000394045BU9 00000379434BU4 00000380940BU7 00000378710BU8 00000344212BU6 00000420895BU5 00000416788BU8 00000415705BU3 00000349342BU6 00000368219BU2 00000375037BU9 00000378066BU5 00000379337BU9 00000341066BU9 00000349343BU4 00000321665BU2 00000324194BU0 00000351993BU1 00000392236BU6 00000392999BU9 00000375409BU0 00000392245BU7 00000340211BU2 00000340822BU6 00000347108BU3 00000416885BU2 00000392766BU2 00000366245BU9 00000392580BU7 00000332824BU2 00000338723BU0 00000340790BU5 00000420495BU4 00000332678BU2 00000385405BU6 00000342460BU3 00000366737BU5 00000394210BU9 00000418299BU4 00000350866BU0 00000367496BU7 00000378074BU9 00000406792BU2 00000393732BU3 00000380199BU0 00000389098BU5 00000403800BU6 00000342699BU6 00000322232BU0 00000410945BU0 00000367087BU4 00000416241BU8 00000366244BU2 00000370167BU9 00000374489BU3 00000399753BU3 00000408875BU3 00000411395BU7 00000327810BU8 00000379404BU7 00000364518BU1 00000399750BU9 00000403125BU8 00000341530BU4 00000419394BU2 00000407955BU4 00000333964BU5 00000334722BU6 00000383540BU2 00000392563BU3 00000338553BU1 00000417921BU4 00000413030BU8 00000416580BU9 00000417594BU9 00000417599BU8 00000309161BU8 00000409163BU3 00000372500BU9 00000351549BU1 00000407957BU0 00000341260BU8 00000382096BU6 00000346259BU5 00004093368BU8 00000367086BU6 00000397644BU6 00000397643BU8 00000389796BU4 00000389994BU5 00000417673BU1 00000419495BU7 00000410336BU2 00000367497BU5 00000381708BU7 00000392468BU5 00000418005BU5 00000368220BU0 00000413390BU6 00000381846BU5 00000341095BU8 00000397050BU6 00000342077BU5 00000382876BU1 00000386741BU3 00000374480BU2 00000381436BU5 00000409300BU1 00000383992BU5 00000382815BU9 00000389501BU8 00000400151BU7 00000364519BU9 00000386059BU0 00000388900BU3 00000407950BU5 00000408333BU3 00000413029BU0 00000404678BU5 00000413030BU8 00000373302BU9 00000375205BU2 00000389096BU9 00000406785BU6 00000374684BU9 00000401024BU5 00000411170BU4 00000416729BU2 00000401502BU0 00000401211BU8 00000331854BU0 00000380939BU9 00000340821BU8…
Recall started: Aug. 6, 2009
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Nonconforming Material/Component
What the company told customers: 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.
Recall number: Z-0393-2011

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

Source: FDA · Medical device enforcement reports, recall numbers Z-0392-2011, Z-0393-2011. The agency record governs; check it and the company before acting.

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