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Class 2 Device Recall GE Healthcare Innova |
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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
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Product Classification |
Fluoroscopic Imaging System - Product Code MQB
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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
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For Additional Information Contact |
608-221-1551
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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.
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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
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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.
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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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