Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump
Publicado el 20 de mayo de 2026 · Inicio del retiro: 8 de abril de 2026
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Medtronic Neuromodulation
- Distribuidor
- Worldwide distribution.
- Lote
- Software application (app) version 1.x and 2.x, loaded on the following units: 1. Model Number CT900A, GTIN 00643169890923, Serial Numbers: NPL0004445; 2. Model Number CT900B, GTIN 00643169890947, Serial Numbers: NPL1000042, NPL1000045, NPL1000046, NPL1000048, NPL1000050, NPL1000051, NPL1000053, NPL1000054, NPL1000059, NPL1000060, NPL1000062, NPL1000065, NPL1000069, NPL1000070, NPL1000071, NPL1000072, NPL1000073, NPL1000074, NPL1000075, NPL1000077, NPL1000081, NPL1000082, NPL1000083, NPL1000085, NPL1000086, NPL1000087, NPL1000090, NPL1000091, NPL1000093, NPL1000094, NPL1000098, NPL1000117, NPL1000133, NPL1000135, NPL1000137, NPL1000138, NPL1000151, NPL1000159, NPL1000160, NPL1000164, NPL1000166, NPL1000167, NPL1000169, NPL1000173, NPL1000174, NPL1000179, NPL1000180, NPL1000183, NPL1000185, NPL1000186, NPL1000187, NPL1000188, NPL1000191, NPL1000192, NPL1000193, NPL1000194, NPL1000195, NPL1000196, NPL1000230, NPL1000235, NPL1000237, NPL1000242, NPL1000244, NPL1000245, NPL1000246, NPL1000248, NPL1000249, NPL1000252, NPL1000254, NPL1000257, NPL1000258, NPL1000281, NPL1000292, NPL1000297, NPL1000301, NPL1000303, NPL1000307, NPL1000321, NPL1000322, NPL1000323, NPL1000325, NPL1000326, NPL1000332, NPL1000334, NPL1000343, NPL1000361, NPL1000362, NPL1000363, NPL1000364, NPL1000365, NPL1000366, NPL1000367, NPL1000369, NPL1000370, NPL1000381, NPL1000483, NPL1000486, NPL1000487, NPL1000501, NPL1000502, NPL1000505, NPL1000506, NPL1000507, NPL1000509, NPL1000510, NPL1000512, NPL1000515, NPL1000516, NPL1000518, NPL1000519, NPL1000528, NPL1000529, NPL1000539, NPL1000540, NPL1000555, NPL1000556, NPL1000558, NPL1000560, NPL1000561, NPL1000562, NPL1000563, NPL1000564, NPL1000571, NPL1000573, NPL1000574, NPL1000575, NPL1000576, NPL1000577, NPL1000578, NPL1000580, NPL1000585, NPL1000592, NPL1000603, NPL1000606, NPL1000612, NPL1000627, NPL1000630, NPL1000631, NPL1000632, NPL1000634, NPL1000637, NPL1000641, NPL1000652, NPL1000653, NPL1001194, NPL1001195, NPL1001201, NPL1001204, NPL1001205, NPL1001206, NPL1001207, NPL1001208, NPL1001210, NPL1001211, NPL1001212, NPL1001216, NPL1001223, NPL1001224, NPL1001225, NPL1001226, NPL1001228, NPL1001229, NPL1001230, NPL1001231, NPL1001235, NPL1001236, NPL1001237, NPL1001238, NPL1001240, NPL1001241, NPL1001243, NPL1001244, NPL1001250, NPL1001251, NPL1001254, NPL1001259, NPL1001264, NPL1001265, NPL1001272, NPL1001273, NPL1001274, NPL1001277, NPL1001282, NPL1001283, NPL1001290, NPL1001291, NPL1001306, NPL1001307, NPL1001313, NPL1001314, NPL1001328, NPL1001330, NPL1001332, NPL1001333, NPL1001334, NPL1001336, NPL1001337, NPL1001339, NPL1001341, NPL1001345, NPL1001349, NPL1001350, NPL1001351, NPL1001353, NPL1001354, NPL1001360, NPL1001361, NPL1001362, NPL1001366, NPL1001367, NPL1001369, NPL1001372, NPL1001375, NPL1001380, NPL1001381, NPL1001385, NPL1001386, NPL1001389, NPL1001398, NPL1001407, NPL1001408, NPL1001410, NPL1001412, NPL1001419, NPL1001421, NPL1001423, NPL1001430, NPL1001431, NPL1001434, NPL1001435, NPL1001436, NPL1001439, NPL1001445, NPL1001449, NPL1001458, NPL1001461, NPL1001464, NPL1001465, NPL1001468, NPL1001482, NPL1001483, NPL1001486, NPL1001499, NPL1001500, NPL1001505, NPL1001507, NPL1001510, NPL1001512, NPL1001513, NPL1001514, NPL1001518, NPL1001520, NPL1001524, NPL1001526, NPL1001531, NPL1001532, NPL1001537, NPL1001539, NPL1001540, NPL1001541, NPL1001542, NPL1001544, NPL1001545, NPL1001546, NPL1001547, NPL1001549, NPL1001550, NPL1001678, NPL1001689, NPL1001694, NPL1001695, NPL1001697, NPL1001699, NPL1001700, NPL1001701, NPL1001702, NPL1001705, NPL1001707, NPL1001708, NPL1001709, NPL1001710, NPL1001711, NPL1001716, NPL1001717, NPL1001723, NPL1001724, NPL1001727, NPL1001728, NPL1001739, NPL1001740, NPL1001741, NPL1001742, NPL1001743, NPL1001744, NPL1001745, NPL1001748, NPL1001749, NPL1001750, NPL1001754, NPL1001755, NPL1001756, NPL1001757, NPL1001759, NPL1001760, NPL1001761, NPL1001763, NPL1001764, NPL1001765, NPL1001766, NPL1001767, NPL1001769, NPL1001770, NPL1001773, NPL1001777, NPL1001784, N
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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