Hitachi Oasis MRI System
This recall has been terminated (originally issued March 23, 2017).
- Recall Initiated
- April 16, 2015
- Posted
- March 23, 2017
- Terminated
- June 29, 2017
- Recall Number
- Z-1540-2017
- Quantity
- 210 units
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Distribution
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.
Lot / Code Info
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
Root Cause
Software in the Use Environment
Action Taken
Formal notification letters were sent to consignees on 2/13/17. Hitachi Service will update the software at each site during visits.