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OEC Elite Systems with 9-inch Image Intensifier recallZ-2278-2023 · GE OEC Medical Systems, Inc · initiated May 15, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE OEC Medical Systems, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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 [email protected] Customers with questions or concerns can contact the firm at 1-800-437-1171

Recall details

Recall number
Z-2278-2023
Status
Open, Classified
Initiated by the company
May 15, 2023
Posted by the FDA
Jul 31, 2023
Recalling firm
GE OEC Medical Systems, Inc
Quantity
812
Product code
OWB
FDA submissions
K192819, K170752, K171565, K172550
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.

Product description

OEC Elite Systems with 9-inch Image Intensifier

Code information (models, lots, serial numbers)

Show the full code information (11k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 92504).

Sources and updates

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