FDA · Medical device recall

GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System… and 4 more products

Sept. 24, 2009

Date posted by the FDA: Sept. 24, 2009
Status: Terminated
Filed by: Ge Healthcare
Reason: GE Healthcare has become aware of an Air Kerma Rate issue associated with a large Equivalent Patient Thickness (EPT) on the Innova system that my impact patient safety. During a Maximum Air Kerma Rate (AKR) calibration procedure check, GE Healthcare found the AKR calibration procedure does not exactly reflect the worst-case clinical usage of the product. This may result, when using large Equival
Distribution pattern: Nationwide Distribution -- United States including Puerto Rico and Guam.

5 products in this recall

GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System…

Product: GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, 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). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
Quantity: 929 units total
Codes and lots: Serial Numbers: 00000549014BU9 00000559113BU6 00000468132BU6 00000550787BU6 00000476562BU4 00000504278BU3 00000541267BU1 00000504213BU0 00000543793BU4 00000471654BU4 00000493726BU4 00000484054BU2 00000480361BU5 00000491716BU7 00000480141BU1 00000478109BU2 00000551073BU0 00000542139BU1 00000548596BU6 00000568569BU8 00000492255BU5 00000548503BU2 00000545486BU3 00000552387BU3 00000485315BU6 00000558901BU5 00000466659BU0 00000470059BU7 00000466984BU2 00000572055BU2 00000505180BU0 00000499524BU7 00000473103BU0 00000544810BU5 00000566379BU4 00000566835BU5 00000499523BU9 00000500515BU0 00000571259BU1 00000472240BU1 00000499386BU1 00000559819BU8 00000551081BU3 00000484361BU1 00000564503BU1 00000549262BU4 00000551080BU5 00000520192BU6 00000490443BU9 00000476249BU8 00000461599BU3 00000533867BU8 00000537820BU3 00000054776BU4 00000548841BU6 00000543266BU1 00000551641BU4 00000512954BU9 00000493888BU2 00000518354BU6 00000553078BU1 00000469582BU1 00000545962BU3 00000485032BU7 00000566594BU8 00000468193BU8 00000570102BU4 00000569024BU3 00000545490BU5 00000543797BU5 00000509365BU3 00000560479BU8 00000479585BU2 00000548595BU8 00000543796BU7 00000531109BU7 00000552382BU4 00000460641BU4 00000460969BU9 00000550786BU8 00000504275BU9 00000493887BU4 00000563630BU3 00000552746BU0 00000563628BU7 00000531111BU3 00000569371BU8 00000513959BU7 00000466830BU7 00000473099BU0 00000479758BU5 00000479243BU8 00000477389BU1 00000500616BU8 00000509440BU4 00000566146BU7 00000491709BU2 00000543076BU4 00000546168BU6 00000561529BU9 00000509441BU2 00000491706BU8 00000562976BU1 00000553276BU7 00000477893BU2 00000546167BU8 00000560911BU0 00000515486BU9 00000537597BU7 00000564215BU2 00000538055BU5 00000493727BU2 00000562518BU1 00000508010BU6 00000559585BU5 00000560474BU9 00000552390BU7 00000483161BU6 00000559233BU2 00000479216BU4 00000465375BU4 00000483162BU4 000000006U0007 00000533870BU2 00000552055BU6 00000556787BU0 00000500612BU7 00000567993BU1 00000569026BU8 00000567352BU0 00000567338BU9 00000509439BU6 00000464559BU4 00000463841BU7 00000479937BU5 00000499840BU7 00000567334BU8 00000493725BU6 00000544289BU2 00000560909BU4 00000552385BU7 00000469466BU7 00000543169BU7 00000542273BU8 00000467455BU2 00000492106BU0 00000546157BU9 00000492922BU0 00000567350BU4 00000552386BU5 00000565106BU2 00000517924BU7 00000547292BU3 00000538034BU0 00000513294BU9 00000471760BU9 00000548165BU0 00000471487BU9 00000468168BU0 00000476109BU4 00000523240BU0 00000461379BU0 00000542138BU3 00000478363BU5 00000504277BU5 00000480315BU1 00000480140BU3 00000479701BU5 00000476013BU8 00000492457BU7 00000513296BU4 00000538053BU0 00000545052BU3 00000541271BU3 00000477463BU4 00000511494BU7 00000548592BU5 00000551634BU9 00000468192BU0 00000469465BU9 00000470060BU5 00000545048BU1 00000523777BU1 00000545046BU5 00000461266BU9 00000523086BU7 00000516769BU7 00000538572BU9 00000537027BU5 00000540176BU5 00000553269BU2 00000491032BU9 00000543265BU3 00000543798BU3 00000548598BU2 00000540174BU0 00000544495BU5 00000542274BU6…
Recall started: Oct. 9, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Consignees were sent a GE Healthcare "Important electronic Product Radiation Warning" letter dated November 3, 2008. The letter was addressed to Healthcare Administrator/Risk Managers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Defect Description and Related Hazards, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact the GE Healthcare Technical Support Center at 1-800-437-1171.
Recall number: Z-1687-2009

GE Innova 3100…

Product: GE Innova 3100, Cardiovascular Imaging System, 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). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
Quantity: 929 units total
Codes and lots: Serial Numbers: 00000529517BU5 00000458534BU5 00000435031BU0 00000566382BU8 00000512956BU4 00000550134BU1 00000549706BU0 00000523132BU9 00000537463BU2 00000547770BU8 00000446090BU3 00000491058BU4 00000537465BU7 00000476260BU5 00000530412BU6 00000555080BU1 00000437215BU7 00000465048BU7 00000482707BU7 00000541969BU2 00000488003BU5 00000545420BU2 00000556280BU6 00000484393BU4 00000544285BU0 00000523134BU5 00000477394BU1 00000482419BU9 00000551636BU4 00000509132BU7 00000568027BU7 00000543272BU9 00000545590BU2 00000548338BU3 00000482661BU6 00000440229BU3 00000521654BU4 00000544808BU9 00000565460BU3 00000520189BU2 00000512758BU4 00000509817BU3 00000545421BU0 00000482188BU0 00000477767BU8 00000557461BU1 00000445301BU5 00000543795BU9 00000424103BU0 00000545419BU4 00000454181BU9 00000449819BU2 00000463520BU7 00000552743BU7 00000548601BU4 00000442172BU3 00451726BU4BU8 00000497601BU5 00000438668BU6 00000492274BU6 00000505219BU6 00000567995BU6 00000571256BU7 00000465766BU4 00000466810BU9 00000553071BU2 00000511912BU8 00000543120BU0 00000552383BU2 00000512958BU0 00000556788BU8 00000464558BU6 00000466829BU9 00000533868BU6 00000548599BU0 00000520410BU2 00000463833BU4 00000570110BU7 00000549016BU4 00000546576BU0 00000470050BU6 00000544812BU1 00000510017BU7 00000548838BU2 00000557169BU0 00000449428BU2 00000496906BU9 00000570359BU0 00000443952BU7 00000437218BU1 00000461906BU0 00000544203BU3 00000434779BU5 00000505176BU8 00000446502BU7 00000496041BU5 00000521649BU4 00000492423BU9 00000484907BU1 00000485033BU5 00000487475BU6 00000520970BU5 00000463464BU8 00000553267BU6 00000547211BU3 00000545045BU7 00000524175BU7 00000493821BU3 00000558167BU3 00000523775BU5 00000570104BU0 00000452492BU2 00000485087BU1 00000450075BU7 00000479764BU3 00000434782BU9 00000537446BU7 00000452493BU0 00000460068BU0 00000570350BU9 00000558166BU5 00000568028BU5 00000556511BU4 00000459558BU3 00000543264BU6 00000557172BU4 00000514330BU0 00000509481BU8 00000479441BU7 00000479625BU6 00000556987BU6 00000544976BU4 00000441966BU9 00000467462BU8 00000459647BU4 00000467645BU8 00000463372BU3 00000539717BU9 00000461405BU3 00000557170BU8 00000439643BU8 00000460292BU6 00000514047BU0 00000445175BU3 00000485405BU5 00000531110BU5 00000047210BU7 00000479704BU9 00000433021BU3 00000557460BU3 00000555006BU6 00000548594BU1 00000538051BU4 00000447647BU9 00000548331BU8 00000423871BU3 00000429683BU6 00000438670BU2 00000498017BU3 00000547293BU1 00000567353BU8 00000447877BU2 00000555007BU4 00000560234BU7 00000546435BU9 00000460426BU0 00000552103BU4 00000552056BU4 00000512955BU6 00000568031BU9 00000521645BU2 00000514742BU6 00000457662BU5 00000547956BU3 00000518370BU2 00000458814BU1 00000458106BU2 00000499841BU5 00000490965BU1 00000423793BU9 00004994239BU2 00000438965BU6 00000439427BU6 00000453192BU7 00000441134BU4 00000546573BU7 00000566842BU1 00000553072BU0 00000435189BU6 00000551947BU5 00000538571BU1 00000541274BU7 00000548333BU4 00000463834BU2 00000558903BU1 00000554126BU3 00000512762BU6 00000546170BU2…
Recall started: Oct. 9, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Consignees were sent a GE Healthcare "Important electronic Product Radiation Warning" letter dated November 3, 2008. The letter was addressed to Healthcare Administrator/Risk Managers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Defect Description and Related Hazards, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact the GE Healthcare Technical Support Center at 1-800-437-1171.
Recall number: Z-1688-2009

GE Innova 3100-IQ…

Product: GE Innova 3100-IQ, Cardiovascular Imaging System, 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). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
Quantity: 929 units total
Codes and lots: Serial Numbers: 00000529517BU5 00000458534BU5 00000435031BU0 00000566382BU8 00000512956BU4 00000550134BU1 00000549706BU0 00000523132BU9 00000537463BU2 00000547770BU8 00000446090BU3 00000491058BU4 00000537465BU7 00000476260BU5 00000530412BU6 00000555080BU1 00000437215BU7 00000465048BU7 00000482707BU7 00000541969BU2 00000488003BU5 00000545420BU2 00000556280BU6 00000484393BU4 00000544285BU0 00000523134BU5 00000477394BU1 00000482419BU9 00000551636BU4 00000509132BU7 00000568027BU7 00000543272BU9 00000545590BU2 00000548338BU3 00000482661BU6 00000440229BU3 00000521654BU4 00000544808BU9 00000565460BU3 00000520189BU2 00000512758BU4 00000509817BU3 00000545421BU0 00000482188BU0 00000477767BU8 00000557461BU1 00000445301BU5 00000543795BU9 00000424103BU0 00000545419BU4 00000454181BU9 00000449819BU2 00000463520BU7 00000552743BU7 00000548601BU4 00000442172BU3 00451726BU4BU8 00000497601BU5 00000438668BU6 00000492274BU6 00000505219BU6 00000567995BU6 00000571256BU7 00000465766BU4 00000466810BU9 00000553071BU2 00000511912BU8 00000543120BU0 00000552383BU2 00000512958BU0 00000556788BU8 00000464558BU6 00000466829BU9 00000533868BU6 00000548599BU0 00000520410BU2 00000463833BU4 00000570110BU7 00000549016BU4 00000546576BU0 00000470050BU6 00000544812BU1 00000510017BU7 00000548838BU2 00000557169BU0 00000449428BU2 00000496906BU9 00000570359BU0 00000443952BU7 00000437218BU1 00000461906BU0 00000544203BU3 00000434779BU5 00000505176BU8 00000446502BU7 00000496041BU5 00000521649BU4 00000492423BU9 00000484907BU1 00000485033BU5 00000487475BU6 00000520970BU5 00000463464BU8 00000553267BU6 00000547211BU3 00000545045BU7 00000524175BU7 00000493821BU3 00000558167BU3 00000523775BU5 00000570104BU0 00000452492BU2 00000485087BU1 00000450075BU7 00000479764BU3 00000434782BU9 00000537446BU7 00000452493BU0 00000460068BU0 00000570350BU9 00000558166BU5 00000568028BU5 00000556511BU4 00000459558BU3 00000543264BU6 00000557172BU4 00000514330BU0 00000509481BU8 00000479441BU7 00000479625BU6 00000556987BU6 00000544976BU4 00000441966BU9 00000467462BU8 00000459647BU4 00000467645BU8 00000463372BU3 00000539717BU9 00000461405BU3 00000557170BU8 00000439643BU8 00000460292BU6 00000514047BU0 00000445175BU3 00000485405BU5 00000531110BU5 00000047210BU7 00000479704BU9 00000433021BU3 00000557460BU3 00000555006BU6 00000548594BU1 00000538051BU4 00000447647BU9 00000548331BU8 00000423871BU3 00000429683BU6 00000438670BU2 00000498017BU3 00000547293BU1 00000567353BU8 00000447877BU2 00000555007BU4 00000560234BU7 00000546435BU9 00000460426BU0 00000552103BU4 00000552056BU4 00000512955BU6 00000568031BU9 00000521645BU2 00000514742BU6 00000457662BU5 00000547956BU3 00000518370BU2 00000458814BU1 00000458106BU2 00000499841BU5 00000490965BU1 00000423793BU9 00004994239BU2 00000438965BU6 00000439427BU6 00000453192BU7 00000441134BU4 00000546573BU7 00000566842BU1 00000553072BU0 00000435189BU6 00000551947BU5 00000538571BU1 00000541274BU7 00000548333BU4 00000463834BU2 00000558903BU1 00000554126BU3 00000512762BU6 00000546170BU2…
Recall started: Oct. 9, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Consignees were sent a GE Healthcare "Important electronic Product Radiation Warning" letter dated November 3, 2008. The letter was addressed to Healthcare Administrator/Risk Managers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Defect Description and Related Hazards, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact the GE Healthcare Technical Support Center at 1-800-437-1171.
Recall number: Z-1689-2009

GE Innova 4100…

Product: GE Innova 4100, 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). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
Quantity: 929 units total
Codes and lots: Serial Numbers: 00000486055BU7 00000470682BU6 00000452644BU8 00000569022BU7 00000485314BU9 00000560473BU1 00000567345BU4 00000567343BU9 00000436341BU2 00000420851BU8 00000416960BU3 00000562417BU6 00000569374BU2 00000479929BU2 00000476623BU4 00000444365BU3 00000468194BU6 00000567994BU9 00000442706BU8 00000431433BU2 00000520407BU8 00000556127BU9 00000568032BU7 00000043751BU3 00000438338BU6 00000441169BU0 00000432631BU0 00000510846BU9 00000563629BU5 00000454700BU6 00000423362BU3 00000458514BU7 00000534727BU3 00000477896BU5 00000441137BU7 00000476261BU3 00000470681BU8 00000541065BU9 00000523133BU7 00000553597BU6 00000439213BU0 00000447876BU4 00000542136BU7 00000419171BU4 00000558898BU3 00000543121BU8 00000562972BU0 00000538056BU3 00000560914BU4 00000437342BU9 00000556508BU0 00000544811BU3 00000552740BU3 00000408040BU4 00000563631BU1 00000411137BU3 00000549015BU6 00000437304BU9 00000465557BU7 00000545044BU0 00000421391BU4 00000438667BU8 00000492456BU9 00000560476BU4 00000451589BU6 00000559584BU8 00000529811BU2 00000482326BU6 00000561531BU5 00000428412BU1 00000437511BU9 00000566838BU9 00000505177BU6 00000445906BU1 00000409937BU0 00000486496BU3 00000415776BU4 00000415045BU4 00000422564BU5 00000452175BU3 00000471490BU3 00000452282BU7 00000530409BU2 00000516768BU9 00000510845BU1 00000427056BU7 00000541266BU3 00000568029BU3 00000509480BU0 00000497553BU8 00000537447BU5 00000430867BU2 00000431502BU4 00000452126BU6 00000426557BU5 00000556284BU8 00000421698BU2 00000543267BU9 00000442436BU2 00000415816BU8 00000443912BU1 00000562973BU8 00000533874BU4 00000551079BU7 00000556985BU0 00000485439BU4 00000559114BU4 00000439928BU3 00000421241BU1 00000466809BU1 00000518372BU8 00000433006BU4 00000454264BU3 00000559813BU1 00000456666BU7 00000480416BU7 00000560908BU6 00000464091BU8 00000544286BU8 00000566144BU2 00000561528BU1 00000564504BU9 00000449427BU4 00000417375BU3 00000555655BU0 00000547769BU0 00000512467BU2 00000544636BU4 00000537462BU4 00000452938BU4 00000493964BU1 00000464038BU9 00000429295BU9 00000472254BU2 00000505196BU6 00000548339BU1 00000544973BU1 00000441754BU9 00000459476BU8 00000415698BU0 00000422530BU6 00000421310BU4 00000404441BU8 00000567351BU2 00000468124BU3 00000420529BU0 00000498622BU0 00000427699BU4 00000537466BU5 00000547030BU7 00000423544BU6 00000555082BU7 00000560910BU2 00000451813BU0 00000521653BU6 00000451980BU7 00000412259BU4 00000441126BU0 00000486012BU8 00000492261BU3 00000560228BU9 00000444938BU5 00000548334BU2 00000446439BU2 00000568030BU1 00000558894BU2 00000426862BU9 00000438324BU6 00000450628BU3 00000416642BU7 00000437985BU5 00000442867BU8 00000427980BU8 00000410733BU0 00000433743BU2 00000562980BU3 00000403984BU8 00000486024BU3 00000436759BU5 00000442603BU7 00000563635BU2 00000559112BU8 00000552391BU5 00000498623BU8 00000433946BU1 00000558896BU7 00000458501BU4 00000553275BU9 00000568026BU9 000000006U0009 00000438341BU0 00000497530BU6 00000519391BU7 00000508960BU2 00000425774BU7 00000532542BU8 00000494957BU4 00000529812BU0…
Recall started: Oct. 9, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Consignees were sent a GE Healthcare "Important electronic Product Radiation Warning" letter dated November 3, 2008. The letter was addressed to Healthcare Administrator/Risk Managers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Defect Description and Related Hazards, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact the GE Healthcare Technical Support Center at 1-800-437-1171.
Recall number: Z-1690-2009

GE Innova 4100-IQ…

Product: GE Innova 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). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
Quantity: 929 units total
Codes and lots: Serial Numbers: 00000486055BU7 00000470682BU6 00000452644BU8 00000569022BU7 00000485314BU9 00000560473BU1 00000567345BU4 00000567343BU9 00000436341BU2 00000420851BU8 00000416960BU3 00000562417BU6 00000569374BU2 00000479929BU2 00000476623BU4 00000444365BU3 00000468194BU6 00000567994BU9 00000442706BU8 00000431433BU2 00000520407BU8 00000556127BU9 00000568032BU7 00000043751BU3 00000438338BU6 00000441169BU0 00000432631BU0 00000510846BU9 00000563629BU5 00000454700BU6 00000423362BU3 00000458514BU7 00000534727BU3 00000477896BU5 00000441137BU7 00000476261BU3 00000470681BU8 00000541065BU9 00000523133BU7 00000553597BU6 00000439213BU0 00000447876BU4 00000542136BU7 00000419171BU4 00000558898BU3 00000543121BU8 00000562972BU0 00000538056BU3 00000560914BU4 00000437342BU9 00000556508BU0 00000544811BU3 00000552740BU3 00000408040BU4 00000563631BU1 00000411137BU3 00000549015BU6 00000437304BU9 00000465557BU7 00000545044BU0 00000421391BU4 00000438667BU8 00000492456BU9 00000560476BU4 00000451589BU6 00000559584BU8 00000529811BU2 00000482326BU6 00000561531BU5 00000428412BU1 00000437511BU9 00000566838BU9 00000505177BU6 00000445906BU1 00000409937BU0 00000486496BU3 00000415776BU4 00000415045BU4 00000422564BU5 00000452175BU3 00000471490BU3 00000452282BU7 00000530409BU2 00000516768BU9 00000510845BU1 00000427056BU7 00000541266BU3 00000568029BU3 00000509480BU0 00000497553BU8 00000537447BU5 00000430867BU2 00000431502BU4 00000452126BU6 00000426557BU5 00000556284BU8 00000421698BU2 00000543267BU9 00000442436BU2 00000415816BU8 00000443912BU1 00000562973BU8 00000533874BU4 00000551079BU7 00000556985BU0 00000485439BU4 00000559114BU4 00000439928BU3 00000421241BU1 00000466809BU1 00000518372BU8 00000433006BU4 00000454264BU3 00000559813BU1 00000456666BU7 00000480416BU7 00000560908BU6 00000464091BU8 00000544286BU8 00000566144BU2 00000561528BU1 00000564504BU9 00000449427BU4 00000417375BU3 00000555655BU0 00000547769BU0 00000512467BU2 00000544636BU4 00000537462BU4 00000452938BU4 00000493964BU1 00000464038BU9 00000429295BU9 00000472254BU2 00000505196BU6 00000548339BU1 00000544973BU1 00000441754BU9 00000459476BU8 00000415698BU0 00000422530BU6 00000421310BU4 00000404441BU8 00000567351BU2 00000468124BU3 00000420529BU0 00000498622BU0 00000427699BU4 00000537466BU5 00000547030BU7 00000423544BU6 00000555082BU7 00000560910BU2 00000451813BU0 00000521653BU6 00000451980BU7 00000412259BU4 00000441126BU0 00000486012BU8 00000492261BU3 00000560228BU9 00000444938BU5 00000548334BU2 00000446439BU2 00000568030BU1 00000558894BU2 00000426862BU9 00000438324BU6 00000450628BU3 00000416642BU7 00000437985BU5 00000442867BU8 00000427980BU8 00000410733BU0 00000433743BU2 00000562980BU3 00000403984BU8 00000486024BU3 00000436759BU5 00000442603BU7 00000563635BU2 00000559112BU8 00000552391BU5 00000498623BU8 00000433946BU1 00000558896BU7 00000458501BU4 00000553275BU9 00000568026BU9 000000006U0009 00000438341BU0 00000497530BU6 00000519391BU7 00000508960BU2 00000425774BU7 00000532542BU8 00000494957BU4 00000529812BU0…
Recall started: Oct. 9, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Consignees were sent a GE Healthcare "Important electronic Product Radiation Warning" letter dated November 3, 2008. The letter was addressed to Healthcare Administrator/Risk Managers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Defect Description and Related Hazards, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact the GE Healthcare Technical Support Center at 1-800-437-1171.
Recall number: Z-1691-2009

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

Source: FDA · Medical device enforcement reports, recall numbers Z-1687-2009, Z-1688-2009, Z-1689-2009, Z-1690-2009, Z-1691-2009. The agency record governs; check it and the company before acting.

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