FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: Hitachi Oasis MRI System
- Recall number
- Z-1540-2017
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- Hitachi Oasis MRI System
- Status
- Terminated
- Initiated
- 2015-04-16
- Posted
- 2017-03-23
- Terminated
- 2017-06-29
- Reason
- Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
- Root cause
- Software in the Use Environment
- Action
- Formal notification letters were sent to consignees on 2/13/17. Hitachi Service will update the software at each site during visits.
- Quantity
- 210 units
- 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, serial or model codes
- 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
- 510(k) numbers
- ["K153547"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 1528028
- Firm city
- Twinsburg
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28