Hitachi Medical Systems America Inc: Medical Device Recall in 2017 - (Recall #: Z-1540-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Hitachi Oasis MRI System

Product Classification:

Class II

Date Initiated: April 16, 2015

Date Posted: March 29, 2017

Recall Number: Z-1540-2017

Event ID: 76373

Reason for Recall:

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

Status: Terminated

Product Quantity: 210 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated