GE OEC Medical Systems, Inc: OEC Elite Systems with 9-inch Image Intensifier

Recall number

Z-2278-2023

Recalling firm

GE OEC Medical Systems, Inc

Product

OEC Elite Systems with 9-inch Image Intensifier

Status

Open, Classified

Initiated

2023-05-15

Posted

2023-07-31

Terminated

not on file

Reason

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

Root cause

Process control

Action

On 5/15/23 correction notices were mailed to: Director/Manager of Radiology, Hospital Administrator, Head of Radiology Department, PACS Administrator, Director of IT Department, Head, Biomedical Engineering, who were asked to do the following: You can continue to use your device. When transporting the device, ensure it is always in the Anterior Posterior (AP) position, as instructed in the systems Operator Manual. Use caution when moving system to avoid a large impact force. In addition, customers were asked to complete and return the acknowledgement response form to fieldactionssurgery@ge.com Customers with questions or concerns can contact the firm at 1-800-437-1171

Quantity

812

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Colombia, Czechia, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, France, Georgia, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, KOREA, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Nepal, New Caledonia, New Zealand, Nigeria, Paraguay, Peru, Poland, Portugal, Romania, Russia, Singapore, Spain, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom, Uruguay, Vietnam.

Lot, serial or model codes

UDI-DI: 00840682121729 Serial Numbers: FSXXTX00180, FSXXXX00020, F9XXTX00007, F9XXTX00008, F9XXXX00021, FSXXTX00068, FSXXTX00303, FSXXXX00054, FSXXTX00333, FSXXTX00272, F9XXXX00046, FSXXXX00009, FSXXXX00005, FSXXTX00350, F9XXTX00025, FSXXTX00131, FSXXTX00103, FSXXTX00116, FSXXTX00073, FSXXXX00056, FSXXTX00120, FSXXTX00171, FSXXTX00307, FSXXXX00006, FSXXTX00153, FSXXTX00154, FSXXTX00214, FSXXTX00048, FSXXTX00062, FSXXTX00170, FSXXTX00172, FSXXTX00362, FSXXTX00368, FSXXXX00024, F9XXTX00202, FSXXTX00326, FSXXTX00260, FSXXTX00133, FSXXXX00011, FSXXTX00286, F9XXTX00045, FSXXTX00241, FSXXTX00179, FSXXTX00276, FSXXTX00396, FSXXTX00034, FSXXTX00359, FSXXTX00248, FSXXXX00057, FSXXTX00079, FSXXTX00274, FSXXXX00032, FSXXTX00331, FSXXTX00042, FSXXTX00114, FSXXXX00007, FSXXTX00345, FSXXTX00065, FSXXTX00173, FSXXTX00191, FSXXTX00123, FSXXTX00376, F9XXTX00238, FSXXTX00234, FSXXTX00107, FSXXTX00298, F9XXXX00050, FSXXXX00036, FSXXXX00039, FSXXTX00373, FSXXTX00338, FSXXTX00382, FSXXTX00045, FSXXTX00118, F9XXTX00155, F9XXTX00179, FSXXTX00305, F9XXTX00053, FSXXTX00119, FSXXTX00135, FSXXTX00136, FSXXTX00221, FSXXXX00063, FSXXTX00067, FSXXTX00244, FSXXXX00062, FSXXTX00060, F9XXTX00059, FSXXTX00204, F9XXTX00040, FSXXTX00036, FSXXTX00099, F9XXTX00149, F9XXXX00013, F9XXXX00028, F9XXTX00019, FSXXTX00327, F9XXTX00017, F9XXTX00018, FSXXTX00216, FSXXTX00414, FSXXTX00315, FSXXTX00209, F9XXTX00121, F9XXTX00153, FSXXTX00027, FSXXTX00158, FSXXTX00231, FSXXTX00405, FSXXTX00406, FSXXTX00072, F9XXTX00030, FSXXTX00413, F9XXTX00196, F9XXTX00157, F9XXTX00158, F9XXTX00241, F9XXTX00248, FSXXTX00053, FSXXTX00054, FSXXTX00323, FSXXXX00010, FSXXTX00407, FSXXTX00049, FSXXTX00193, FSXXTX00220, FSXXTX00149, FSXXTX00150, FSXXTX00208, FSXXTX00168, FSXXTX00240, FSXXXX00061, FSXXTX00029, FSXXXX00045, FSXXXX00049, F9XXTX00220, F9XXTX00226, F9XXTX00127, FSXXTX00178, FSXXXX00017, FSXXTX00316, FSXXXX00023, FSXXTX00108, FSXXTX00330, FSXXXX00008, FSXXXX00052, FSXXTX00177, FSXXXX00048, FSXXTX00037, FSXXTX00278, FSXXTX00280, FSXXXX00035, F9XXXX00060, F9XXXX00038, F9XXXX00039, FSXXTX00102, FSXXTX00098, F9XXTX00081, FSXXTX00165, FSXXTX00057, FSXXTX00088, FSXXTX00197, FSXXTX00198, FSXXTX00412, FSXXTX00013, FSXXTX00014, FSXXTX00015, FSXXTX00016, FSXXTX00047, FSXXTX00337, FSXXTX00003, FSXXTX00189, FSXXXX00018, FSXXXX00019, FSXXTX00223, FSXXTX00306, FSXXTX00129, F9XXTX00071, FSXXTX00091, FSXXTX00166, FSXXTX00106, FSXXTX00117, FSXXTX00217, F9XXTX00198, FSXXTX00033, FSXXTX00109, FSXXTX00141, FSXXTX00282, FSXXTX00328, FSXXTX00341, FSXXTX00347, FSXXXX00003, FSXXTX00277, F9XXTX00180, F9XXXX00018, F9XXXX00020, F9XXXX00041, F9XXXX00042, F9XXTX00174, FSXXTX00090, F9XXXX00066, FSXXTX00010, FSXXTX00302, FSXXTX00146, FSXXTX00121, F9XXTX00020, F9XXTX00063, F9XXTX00064, FSXXTX00270, FSXXTX00322, F9XXTX00048, FSXXTX00294, FSXXTX00258, FSXXTX00259, FSXXTX00159, F9XXTX00188, FSXXTX00218, FSXXTX00230, F9XXTX00251, FSXXTX00319, F9XXXX00068, FSXXXX00064, FSXXTX00087, F9XXTX00023, F9XXXX00067, FSXXTX00264, FSXXXX00001, FSXXXX00059, FSXXTX00233, FSXXTX00398, FSXXTX00364, FSXXTX00339, FSXXTX00365, FSXXTX00349, F9XXTX00195, FSXXTX00283, FSXXTX00325, F9XXTX00111, F9XXTX00113, F9XXTX00244, F9XXTX00253, FSXXTX00012, FSXXTX00059, F9XXTX00154, FSXXTX00143, FSXXTX00186, FSXXTX00267, FSXXTX00271, FSXXTX00344, FSXXTX00055, FSXXTX00128, F9XXTX00231, FSXXTX00212, FSXXTX00355, F9XXXX00043, FSXXTX00066, FSXXTX00321, FSXXXX00043, F9XXTX00146, F9XXTX00201, F9XXTX00024, F9XXXX00019, FSXXTX00390, FSXXTX00096, FSXXTX00384, FSXXXX00021, FSXXTX00367, FSXXTX00155, FSXXTX00138, FSXXTX00207, FSXXTX00232, FSXXTX00236, F9XXTX00010, F9XXTX00011, F9XXTX00039, F9XXTX00181, F9XXXX00012, F9XXXX00014, FSXXTX00006, FSXXTX00009, FSXXTX00132, FSXXTX00265, FSXXTX00395, FSXXTX00239, FSXXTX00190, FSXXTX00052, FSXXTX00249, FSXXTX00004, FSXXTX00031, FSXXTX00032, FSXXTX00127, FSXXTX00343, FSXXTX00354, F9XXTX00137, F9XXTX00147, FSXXTX00295, F9XXTX00082, F9XXTX00044, FSXXTX00360, FSXXTX00374, F9XXTX00257, F9XXTX00112, F9XXTX00156, F9XXTX00085, FSXXTX00224, F9XXTX00159, FSXXTX00074, FSXXXX00066, FSXXTX00358, F9XXXX00051, FSXXTX00242, FSXXTX00213, FSXXXX00041, FSXXXX00053, F9XXTX00239, F9XXXX00036, FSXXTX00038, FSXXTX00317, F9XXTX00197, F9XXTX00041, F9XXTX00150, FSXXXX00027, FSXXTX00007, FSXXTX00332, FSXXTX00389, F9XXTX00107, FSXXTX00175, FSXXTX00195, FSXXTX00008, FSXXXX00033, FSXXTX00039, FSXXTX00030, FSXXTX00289, FSXXXX00026, F9XXTX00016, FSXXTX00163, FSXXTX00187, FSXXTX00261, FSXXTX00161, FSXXTX00100, FSXXTX00101, FSXXTX00095, FSXXTX00329, F9XXXX00037, F9XXTX00254, FSXXTX00263, F9XXXX00040, FSXXTX00071, FSXXXX00040, FSXXTX00035, FSXXTX00182, F9XXTX00177, FSXXXX00058, FSXXTX00352, FSXXTX00093, FSXXTX00082, FSXXTX00222, FSXXTX00112, F9XXTX00043, FSXXTX00069, FSXXTX00130, FSXXTX00134, FSXXTX00194, FSXXTX00199, FSXXTX00304, FSXXTX00125, FSXXTX00126, FSXXTX00361, FSXXTX00162, FSXXTX00288, FSXXTX00293, F9XXTX00009, F9XXXX00047, FSXXTX00342, FSXXTX00392, F9XXTX00218, F9XXTX00240, FSXXTX00185, F9XXTX00216, FSXXTX00061, FSXXTX00089, FSXXTX00144, FSXXTX00381, F9XXTX00243, FSXXTX00174, F9XXTX00242, FSXXTX00063, FSXXTX00064, FSXXTX00420, F9XXTX00031, FSXXTX00011, FSXXTX00164, FSXXTX00415, FSXXTX00416, FSXXTX00148, FSXXTX00375, F9XXTX00084, FSXXTX00046, FSXXTX00201, FSXXXX00065, F9XXXX00052, F9XXXX00053, FSXXXX00014, F9XXTX00138, FSXXTX00019, FSXXTX00084, FSXXTX00085, FSXXTX00269, FSXXTX00211, FSXXXX00029, FSXXTX00273, FSXXTX00372, FSXXTX00210, FSXXTX00092, FSXXTX00139, FSXXTX00243, F9XXTX00015, FSXXTX00238, FSXXTX00167, FSXXTX00157, FSXXTX00320, FSXXTX00394, F9XXTX00004, FSXXTX00005, FSXXTX00122, FSXXTX00237, FSXXTX00335, FSXXTX00137, FSXXTX00156, FSXXTX00215, FSXXTX00404, F9XXTX00217, F9XXTX00219, FSXXTX00113, FSXXTX00235, F9XXTX00027, F9XXTX00132, FSXXXX00034, FSXXTX00183, FSXXTX00043, FSXXTX00192, FSXXTX00336, F9XXTX00109, FSXXTX00299, F9XXTX00215, F9XXXX00033, F9XXXX00055, F9XXXX00056, FSXXTX00296, F9XXTX00099, F9XXTX00143, F9XXTX00144, F9XXTX00151, F9XXTX00161, F9XXTX00175, F9XXTX00178, F9XXTX00190, FSXXTX00203, FSXXTX00357, FSXXXX00055, F9XXTX00037, F9XXXX00023, F9XXXX00027, F9XXTX00098, F9XXTX00105, F9XXXX00049, FSXXTX00279, FSXXTX00290, FSXXTX00028, FSXXTX00219, FSXXTX00266, FSXXXX00025, F9XXXX00045, FSXXXX00050, FSXXTX00200, FSXXTX00371, FSXXTX00318, FSXXTX00385, FSXXXX00016, FSXXTX00245, FSXXTX00246, FSXXTX00292, FSXXTX00409, FSXXTX00419, FSXXTX00309, FSXXTX00334, F9XXTX00125, F9XXTX00097, F9XXTX00228, F9XXTX00038, FSXXTX00297, FSXXTX00408, FSXXTX00383, FSXXTX00247, FSXXTX00356, FSXXTX00399, FSXXTX00115, F9XXXX00065, FSXXXX00042, F9XXTX00078, F9XXTX00148, F9XXTX00221, F9XXTX00235, F9XXTX00236, FSXXTX00051, FSXXTX00058, FSXXTX00377, FSXXTX00387, FSXXTX00410, FSXXTX00417, FSXXTX00196, FSXXTX00275, FSXXXX00051, FSXXTX00301, FSXXTX00262, FSXXTX00397, FSXXTX00285, FSXXTX00353, FSXXTX00363, FSXXTX00366, F9XXTX00046, F9XXTX00160, F9XXTX00176, FSXXTX00340, FSXXTX00346, F9XXTX00122, F9XXTX00068, FSXXTX00268, FSXXTX00041, FSXXTX00142, FSXXTX00386, FSXXTX00284, FSXXTX00308, FSXXTX00202, FSXXTX00181, FSXXXX00047, FSXXTX00422, FSXXTX00086, FSXXTX00104, FSXXTX00056, F9XXXX00034, FSXXTX00169, F9XXTX00126, FSXXXX00013, FSXXXX00015, FSXXTX00351, FSXXXX00037, FSXXTX00300, FSXXTX00348, FSXXTX00391, FSXXTX00281, FSXXXX00038, FSXXTX00418, FSXXXX00044, FSXXTX00094, FSXXTX00097, F9XXTX00145, F9XXTX00200, F9XXXX00035, F9XXTX00021, F9XXTX00022, FSXXXX00002, FSXXTX00078, FSXXTX00070, FSXXTX00393, FSXXTX00105, FSXXXX00028, FSXXXX00031, F9XXTX00095, F9XXTX00255, FSXXXX00022, F9XXTX00123, F9XXTX00088, F9XXTX00087, FSXXTX00310, F9XXTX00199, F9XXTX00056, F9XXTX00069, FSXXTX00111, FSXXTX00077, F9XXTX00172, F9XXTX00185, F9XXTX00191, F9XXTX00205, F9XXTX00259, FSXXTX00369, F9XXTX00003, F9XXTX00058, F9XXTX00089, F9XXTX00094, F9XXTX00116, F9XXXX00048, FSXXXX00046, F9XXTX00100, F9XXXX00061, F9XXXX00001, F9XXTX00050, F9XXXX00032, F9XXXX00069, F9XXTX00194, F9XXTX00230, F9XXTX00252, F9XXTX00035, F9XXTX00036, F9XXTX00049, F9XXTX00142, F9XXTX00222, F9XXTX00232, F9XXXX00016, FSXXTX00021, FSXXTX00023, FSXXTX00024, FSXXTX00400, FSXXTX00022, FSXXTX00083, FSXXTX00160, F9XXXX00062, F9XXXX00063, FSXXTX00225, FSXXTX00257, FSXXTX00388, FSXXTX00176, FSXXTX00256, FSXXTX00380, FSXXTX00050, FSXXTX00205, FSXXTX00025, F9XXTX00171, FSXXTX00147, FSXXTX00403, F9XXTX00014, F9XXTX00029, F9XXTX00108, F9XXTX00130, F9XXTX00131, F9XXXX00064, F9XXTX00073, F9XXTX00074, F9XXTX00075, F9XXTX00028, F9XXTX00167, F9XXTX00135, F9XXTX00204, F9XXTX00152, F9XXXX00003, F9XXXX00007, FSXXXX00030, F9XXTX00057, FSXXTX00075, FSXXTX00018, F9XXTX00246, F9XXTX00213, F9XXTX00076, F9XXTX00224, F9XXTX00245, F9XXXX00044, F9XXXX00029, F9XXXX00022, F9XXXX00011, F9XXXX00008, FSXXTX00020, F9XXXX00025, F9XXTX00170, FSXXTX00152, F9XXTX00106, F9XXTX00139, FSXXTX00312, FSXXTX00252, FSXXXX00012, FSXXTX00081, FSXXTX00145, FSXXTX00151, FSXXXX00060, F9XXTX00203, FSXXTX00311, FSXXTX00378, FSXXTX00401, FSXXTX00402, FSXXTX00421, FSXXTX00076, F9XXTX00083, FSXXTX00206, FSXXTX00080, FSXXTX00229, F9XXTX00209, F9XXTX00208, F9XXTX00054, F9XXTX00065, F9XXTX00173, F9XXTX00193, F9XXTX00128, F9XXTX00129, F9XXTX00062, F9XXTX00067, F9XXTX00114, F9XXTX00162, F9XXTX00192, F9XXTX00133, F9XXTX00066, F9XXTX00115, F9XXTX00134, F9XXTX00164, F9XXTX00212, FSXXTX00140, F9XXTX00117, F9XXTX00227, FSXXTX00044, FSXXTX00040, F9XXTZ00001, F9XXTX00072, FSXXTX00026, F9XXXX00057, F9XXXX00058, F9XXXX00059, F9XXXX00004, F9XXTX00042, F9XXTX00005, F9XXTX00012, F9XXTX00013, F9XXXX00024, FSXXTX00226, FSXXTX00227, FSXXTX00250, FSXXTX00253, FSXXTX00254, FSXXXX00067, FSXXTX00228, FSXXTX00184, FSXXTX00287, FSXXTX00370, FSXXTX00379, FSXXXX00068, F9XXTX00006, FSXXTX00324, F9XXTX00233, F9XXTX00237, FSXXTX00313, FSXXTX00017, F9XXTX00165, F9XXTX00096, F9XXTX00234, FSXXTX00314, F9XXTX00077, F9XXTX00258, FSXXTX00110, F9XXTX00136, F9XXTX00141, F9XXTX00070, F9XXTX00214, FSXXTX00124, FSXXTX00188, F9XXTX00093, F9XXXX00054, F9XXTX00140, F9XXTX00186, F9XXTX00079, F9XXTX00223, F9XXTX00187, F9XXTX00086, F9XXXX00070, F9XXTX00225, F9XXTX00184, F9XXTX00206, F9XXTX00207, F9XXTX00256, F9XXTX00080, F9XXTX00103, F9XXTX00104, F9XXXX00015, F9XXXX00017, F9XXTX00061, F9XXTX00166, F9XXTX00052, F9XXTX00026, F9XXTX00183, FSXXTX00251, F9XXTX00060, F9XXTX00189, F9XXTX00211, F9XXXX00006, F9XXXX00031, F9XXTX00034, F9XXTX00055, F9XXTX00249, F9XXTX00101, F9XXTX00102, F9XXTX00110, F9XXTX00119, F9XXTX00090, F9XXTX00091, F9XXTX00092, F9XXTX00210, F9XXXX00009, F9XXXX00010, F9XXTX00169, F9XXTX00051, F9XXTX00118, F9XXTX00120, FSXXTX00291, F9XXTX00247, F9XXTX00032, FSXXTX00255, F9XXTX00182, F9XXXX00030, F9XXTX00033, F9XXTX00047, F9XXTX00124, F9XXTX00168, F9XXTX00250, F9XXXX00026, F9XXTX00229, F9XXTX00163

510(k) numbers

["K170752","K171565","K172550","K192819"]

PMA numbers

not on file

Product code

OWB

Firm FEI

1720753

Firm city

Salt Lake City

Firm state

UT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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