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.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling 713 units of its Innova fluoroscopic imaging systems, including models 2100 IQ, 3100 IQ, 4100 IQ, 2121 IQ, 3131 IQ, 3100, and 4100. These systems are used to generate fluoroscopic images of human anatomy. The recall addresses a potential failure of a relay in the power distribution box that could cause a nonrecoverable loss of imaging modes without advance warning during fluoroscopic examinations. Although no injuries have been reported to date, there is a risk of procedure complications if imaging functionality is lost during use.
The affected systems have been distributed nationwide and internationally, including locations in the Philippines, Peru, Panama, Mexico, Malaysia, Korea, Japan, Guatemala, Ecuador, the Dominican Republic, and Colombia. The source document does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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, Chi Quantity: 713 Lot/code info: 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 000005
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.