Hitachi Oasis MRI System
Reported: March 29, 2017 Initiated: April 16, 2015 #Z-1540-2017
Product Description
Hitachi Oasis MRI System
Reason for Recall
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Details
- Recalling Firm
- Hitachi Medical Systems America Inc
- Units Affected
- 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.
- Location
- Twinsburg, OH
Frequently Asked Questions
What product was recalled? ▼
Hitachi Oasis MRI System. Recalled by Hitachi Medical Systems America Inc. Units affected: 210 units.
Why was this product recalled? ▼
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 29, 2017. Severity: Moderate. Recall number: Z-1540-2017.
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