FDAFDA · Food and drugs·Recall number Z-1318-2013
GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.
Published May 22, 2013 · Recall initiated: December 20, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Worldwide Distribution -- Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, GUAM, HI, ID, IL , IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NH, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WY and WI., and the countries of Philippines, Peru, Paraguay, Panama, Mexico, Malaysia, Korea, Japan, Guatemala, Ecuador, Dominican Republic , Columbia, China, Chile, Canada, Brazil.,Argentina and Venezuela
- Lot
- Serial # 00000520055BU5 00000009C20026 00000007C20159 00000007C20161 00000008C2M001 0000009C2M0068 00000007C20152 00000519147BU3 00000466843BU0 00000489559BU5 00000009C20099 00000009C20109 00000466851BU3 00000008C20053 00000519174BU7 00000008C20312 00000008C20210 00000007C20391 00000007C20039 00000007C20322 00000008C20079 00000478341BU1 00000536797BU4 00000009C20075 00000008C20214 00000009C20017 00000498702BU0 00000498705BU3 00000007C20324 00000008C20221 00000465840BU7 00000007C20198 00000007C20183 00000536791BU7 00000008C20224 00000008C20227 00000478340BU3 0000009C2M0119 0000009C2M0127 00000532669BU9 00000007C20117 00000009C20036 00000520074BU6 00000007C20012 00000008C20084 00000007C20219 00000536790BU9 00000489715BU3 00000519096BU2 00000008C20041 00000453944BU1 00000536805BU5 00000008C20004 00000465797BU9 00000520079BU5 00000009C20100 00000008C20030 00000532657BU4 00000008C20094 0000009C2M0084 00000008C20069 00000007C20374 00000009C20072 00000007C20239 00000008C20106 00000532662BU4 00000009C20105 00000536804BU8 00000007C20081 0000009C2M0016 00000007C20131 00000532665BU7 00000008C20170 00000008C20165 00000489556BU1 00000008C20051 00000008C20211 00000520056BU3 00000008C20304 00000008C20300 00000008C20064 00000008C20179 00000498875BU4 00000008C20045 00000007C20352 00000009C20037 00000007C20123 00000008C20323 00000520068BU8 00000498686BU5 00000008C20269 00000564503BU1 00000007C20195 00000519169BU7 00000007C20073 00000008C20213 00000498881BU2 00000009C20056 00000009C20032 00000519162BU2 00000498708BU7 00000007C20141 00000007C20358 00000008C20351 00000009C20043 00000520047BU2 00000477810BU6 00000519154BU9 00000008C20284 0000008C2M0002 00000532664BU0 00000008C20332 00000519132BU5 00000519149BU9 00000007C20091 00000007C20134 00000536785BU9 0000009C2M0033 00000007C20189 00000007C20004 0000009C2M0029 0000009C2M0070 00000519127BU5 00000007C20218 00000007C20370 00000489713BU8 00000556247BU5 00000489771BU6 00000489691BU6 00000489539BU7 00000489767BU4 0000009C2M0135 00000007C20255 00000007C20250 00000007C20078 00000008C20034 00000008C20019 00000536809BU7 00000520038BU1 00000007C20020 00000008C20167 00000007C20384 00000466853BU9 00000008C20066 00000520042BU3 00000007C20103 00000009C20104 00000489700BU5 00000008C20216 00000008C20283 00000008C20233 00000009C20048 00000008C20225 00000007C20053 00000007C20340 005178429-0137 00000008C20062 00000477797BU5 00000007C20121 00000464077BU7 00000477838BU7 00000536777BU6 00000007C20365 0000009C2M0100 00000007C20028 00000441167BU4 00000007C20231 00000459650BU8 00000007C20176 00000007C20327 00000008C20205 00000536803BU0 0000009C2M0047 0000009C2M0187 00000007C20351 00000008C20076 00000519131BU7 00000007C20072 00000007C20302 00000498699BU8 00000008C20256 00000519118BU4 00000464593BU3 00000008C20337 00000009C20078 00000009C20088 00000007C20284 00000007C20125 0000009C2M0073 00000520085BU2 00000008C20001 00000007C20120 00000008C20176 00000009C20007 00000008C20336 0000000DUMMY02 00000008C20292 00000008C20157 00000008C20331 00000519180BU4 00000008C20047 00000007C20293 00000008C20220 00000007C20376 00000489712BU0 00000008C20127 00000008C20219 00000489773BU2 00000007C20260 00000007C20110 00000007C20064 00000008C20097 00000520080BU3 00000008C20112 00000519168BU9 00000007C20232 00000007C20037 00000498720BU2 00000007C20341 00000008C20033 00000007C20349 00000007C20092 0000009C2M0093 00000007C20249 00000008C20212 00000009C20034 00000008C20202 00000007C20058 00000008C20015 00000007C20209 00000009C20064 00000007C20112 00000520063BU9 00000007C20397 00000007C20237 00000519133BU3 00000009C20031 00000007C20060 00000007C20031 00000498890BU3 00000007C20055 00000007C20201 00000007C20130 00000009C20011 00000007C20290 00000007C20252 00000007C20336 00000009C20041 00000007C20234 000000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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