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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Innova

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  Class 2 Device Recall GE Healthcare Innova see related information
Date Initiated by Firm August 17, 2006
Date Posted September 30, 2008
Recall Status1 Terminated 3 on June 09, 2009
Recall Number Z-1518-2008
Recall Event ID 48977
510(K)Number K050489  K052157  K052412  
Product Classification Fluoroscopic Imaging System - Product Code MQB
Product GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular imaging system). 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 of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
Code Information serial numbers: 00000007C20041, 00000046457BU0, 00000046582BU1, 00000051324BU5, 000000MI000555, 00000454582BU8, 00000455797BU9, 00000459650BU8, 00000459651BU6, 00000459652BU4, 00000459653BU2, 00000459654BU0, 00000459655BU7, 00000459656BU5, 00000459657BU3, 00000459658BU1, 00000459659BU9, 00000459661BU5, 00000459663BU1, 00000459664BU9, 00000459665BU6, 00000459667BU2, 00000459668BU0, 00000459669BU8, 00000459670BU6, 00000459672BU2, 00000459673BU0, 00000459674BU8, 00000459675BU5, 00000459676BU3, 00000459677BU1, 00000459891BU8, 00000464564BU4, 00000464565BU1, 00000464566BU9, 00000464567BU7, 00000464568BU5, 00000464570BU1, 00000464571BU9, 00000464572BU7, 00000464573BU5, 00000464574BU3, 00000464576BU8, 00000464577BU6, 00000464578BU4, 00000464579BU2, 00000464580BU0, 00000464581BU8, 00000464582BU6, 00000464585BU9, 00000464586BU7, 00000464587BU5, 00000464588BU3, 00000464589BU1, 00000464590BU9, 00000464591BU7, 00000464592BU5, 00000464593BU3, 00000465560BU1, 00000465794BU6, 00000465795BU3, 00000465796BU1, 00000465821BU7, 00000465822BU5, 00000465823BU3, 00000465825BU8, 00000465827BU4, 00000465828BU2, 00000465829BU0, 00000465830BU8, 00000465831BU6, 00000465832BU4, 00000465834BU0, 00000465835BU7, 00000465836BU5, 00000465837BU3, 00000465838BU1, 00000465839BU9, 00000465840BU7, 00000465841BU5, 00000465842BU3, 00000465843BU1, 00000465845BU6, 00000465846BU4, 00000465848BU0, 00000465849BU8, 00000466836BU4, 00000466838BU0, 00000466839BU8, 00000466841BU4, 00000466843BU0, 00000466844BU8, 00000466845BU5, 00000466846BU3, 00000466847BU1, 00000466848BU9, 00000466849BU7, 00000466850BU5, 00000466851BU3, 00000466852BU1, 00000466853BU9, 00000466856BU2, 00000466857BU0, 00000466859BU6, 00000466860BU4, 00000466861BU2, 00000466862BU0, 00000466863BU8, 00000466864BU6, 00000466865BU3, 00000478319BU7, 00000478320BU5, 00000478323BU9, 00000478324BU7, 00000478326BU2, 00000478327BU0, 00000478328BU8, 00000478330BU4, 00000478331BU2, 00000478333BU8, 00000478337BU9, 00000478338BU7, 00000478339BU5, 00000478340BU3, 00000478341BU1, 00000478342BU9, 00000478345BU2, 00000478346BU0, 00000478347BU8, 00000478348BU6, 00000485080BU6, 00000489536BU3, 00000489537BU1, 00000489538BU9, 00000489539BU7, 00000489540BU5, 00000489542BU1, 00000489543BU9, 00000489544BU7, 00000489546BU2, 00000489547BU0, 00000489548BU8, 00000489549BU6, 00000489551BU2, 00000489553BU8, 00000489555BU3, 00000489557BU9, 00000489558BU7, 00000489561BU1, 00000489562BU9, 00000489564BU5, 00000489565BU2, 00000489683BU3, 00000489684BU1, 00000489688BU2, 00000489738BU5, 00000489744BU3, 00000489747BU6, 00000489753BU4, 00000489756BU7, 00000489757BU5, 00000489761BU7, 00000489763BU3, 00000489770BU8, 00000489772BU4, 00000498661BU8, 00000498679BU0, 00000498710BU3, 00000498711BU1, 00000498712BU9, 00000498713BU7, 00000498715BU2, 00000498717BU8, 00000498718BU6, 00000498719BU4, 00000498720BU2, 00000498721BU0, 00000498722BU8, 00000498723BU6, 00000508755BU6, 00000509439BU6, 00000512697BU4, 00000512701BU4, 00000512713BU9, 00000512715BU4, 00000512727BU9, 00000512818BU6, 00000512819BU4, 00000512821BU0, 00000512822BU8, 00000512823BU6, 00000512828BU5, 00000512868BU1, 00000512870BU7, 00000512871BU5, 00000512874BU9, 00000512875BU6, 00000512877BU2, 00000512880BU6, 00000512883BU0, 00000512888BU9, 00000512891BU3, 00000512892BU1, 00000512894BU7, 00000512898BU8, 00000513110BU7, 00000513118BU0, 00000513161BU0, 00000513190BU9, 00000513204BU8, 00000513206BU3, 00000513207BU1, 00000513208BU9, 00000513209BU7, 00000513212BU1, 00000513244BU4, 00000513265BU9, 00000513274BU1, 00000513296BU4, 00000513516BU5, 00000513533BU0, 00000513539BU7, 00000513541BU3, 00000513547BU0, 00000513555BU3, 00000513558BU7, 00000513560BU3, 00000513567BU8, 00000519094BU7, 00000519100BU2, 00000519106BU9, 00000519109BU3, 00000519121BU8, 00000519125BU9, 00000519129BU1, 00000519131BU7, 00000520045BU6, 00000520048BU0, 00000520050BU6, 00000520065BU4, 00000520070BU4, 00000520075BU3, 00000520083BU7, 00000526275BU3, 00000526389BU2, 00000526556BU6, 00000526557BU4, 00000526560BU8, 00000526562BU4, 00000526563BU2, 00000526648BU1, 00000526681BU2, 00000529461BU6, 00000530106BU4, 00000530116BU3, 00000530120BU5, 00000530242BU7, 00000530246BU8, 00000530248BU4, 00000530410BU0, 00000530413BU4, 00000536802BU2, 00000538053BU0, 00000543790BU0, 00000544289BU2, 00000545052BU3, 00000546574BU5, 00000547017BU4. systems id: 835160017, 82416070006, 00192VAS05, 214947MINNOVA2, 305682IN2X, 318448INNOVA3, 83INNOVA2588441, B5219603, H0002VAS66, HU1099VA02, RPINNOVA2100, YV0053.
Recalling Firm/
Manufacturer		 Datex - Ohmeda, Inc
Po Box 7550
Madison WI 53707
For Additional Information Contact
608-221-1551
Manufacturer Reason
for Recall		 User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any preset exposure time may lead to incorrect overall dose management, resulting in unnecessary exposure and can be a contributing factor for skin injury. The alarm can be heard in the control room.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE Field Engineers are visiting all affected customers to apply updated software. For assistance contact Datax-Ohmeda, Inc., at 1-608-221-1551.
Quantity in Commerce 281
Distribution within US: AL, AR, AZ, CA,CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico. OUS to include: Algeria, Australia, Belgium, Brazil, Canada, China, Columbia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Malaysia, Mexico, New Zealand, Norway, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Syria, Taiwan, Turkey, and United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = GE HEALTHCARE
510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC
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