Class 2 Device Recall Hitachi Echelon Oval MRI System

• Date Initiated by Firm: April 16, 2015
• Date Posted: March 23, 2017
• Recall Status: Terminated on June 29, 2017
• Recall Number: Z-1541-2017
• Recall Event ID: 76373
• 510(K)Number: K113145 K151015 K153547
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: Hitachi Echelon Oval MRI System
• Code Information: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y013, Y014, Y015, Y016, Y101, Y102, Y103, Y104, Y105, Y106, Y107, Y108, Y951
• Recalling Firm/ Manufacturer: Hitachi Medical Systems America Inc; 1959 Summit Commerce Park; Twinsburg OH 44087-2371
• For Additional Information Contact: Douglas J. Thistlethwaite; 330-425-1313 Ext. 3720
• Manufacturer Reason for Recall: Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
• FDA Determined 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 in Commerce: 25 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LNH