Datex Ohmeda, Inc 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 im Recall
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According to the U.S. Food and Drug Administration (FDA)
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 im
Brand
Datex Ohmeda, Inc
Lot Codes / Batch Numbers
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.
Products Sold
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Datex Ohmeda, Inc is recalling GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular ima due to 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 t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
GE Field Engineers are visiting all affected customers to apply updated software. For assistance contact Datax-Ohmeda, Inc., at 1-608-221-1551.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, PR
Page updated: Jan 10, 2026