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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1540-2017

Hitachi Oasis MRI System

Publicado el 29 de marzo de 2017 · Inicio del retiro: 16 de abril de 2015

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Hitachi Medical Systems America Inc
Distribuidor
US nationwide distribution. The products were distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are four (4) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Building 301 - Andrews Avenue, Fort Rucker, AL 36362; Parma VA Medical Center, 8787 Brookpark Rd, Parma, OH 44129; Viera VA Outpatient Clinic, 2900 Veterans Way, Viera, FL 32940; Perry Point VA Medical Center, Avenue D, Suite 1A-120, Perry Point, MD 21902. There are zero (0) Canada accounts for this recall. There are two (2) Mexico accounts for this recall: Hospital General Tipo "B" de Alta Especialidad - SMH, "Fraccionamiento 1 De La Parcela 101, Del Ejido De Atapaneo", Morelia, MX 58300; Hospital General de Occidente, Zoquipan 1050 Avenue, Zapopan Jalisco, MX 45170 The product was distributed to the following countries: Brazil.
Lote
M001, M002, M003, M004, M005, M006, M007, M008, M009, M010, M011, M012, M013, M014, M015, M016, M017, M018, M019, M020, M021, M022, M023, M024, M025, M026, M027, M028, M030, M031, M032, M033, M034, M035, M036, M037, M038, M039, M040, M041, M042, M043, M044, M045, M046, M047, M048, M049, M050, M051, M052, M053, M054, M055, M056, M057, M058, M059, M060, M061, M062, M063, M064, M065, M066, M067, M068, M069, M070, M071, M072, M073, M074, M075, M076, M077, M078, M079, M080, M081, M082, M083, M084, M085, M086, M087, M088, M089, M090, M091, M092, M093, M094, M095, M096, M097, M098, M099, M100, M101, M102, M103, M104, M105, M106, M107, M108, M110, M111, M112, M113, M114, M115, M116, M117, M118, M119, M120, M121, M122, M123, M124, M125, M126, M127, M128, M129, M130, M131, M132, M133, M134, M135, M136, M137, M138, M139, M140, M141, M142, M143, M144, M145, M146, M147, M148, M149, M150, M151, M152, M153, M154, M155, M156, M157, M158, M159, M160, M161, M162, M163, M164, M165, M166, M167, M168, M169, M170, M171, M172, M173, M174, M175, M176, M177, M178, M179, M180, M181, M182, M183, M184, M185, M186, M187, M188, M189, M190, M191, M192, M193, M194, M195, M196, M197, M198, M199, M200, M201, M202, M203, M204, M205, M206, M207, M208, M209, M210, M951, M952
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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