Hitachi Echelon MRI System recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

V001, V002, V003, V004, V005, V006, V007, V008, V009, V010, V011, V012, V013, V014, V015, V016, V017, V018, V020, V021, V022, V023, V024, V025, V026, V027, V028, V029, V030, V031, V032, V033, V034, V035, V036, V037, V038, V039, V040, V041, V042, V043, V044, V045, V046, V047, V048, V049, V050, V051, V052, V053, V054, V055, V056, V057, V058, V059, V060, V061, V062, V063, V064, V065, V066, V067, V068, V952

Product

Hitachi Echelon MRI System

Recalling firm

Hitachi Medical Systems America Inc

Quantity

68 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.

Recall date

March 29, 2017

Classification

Class II

Status

Terminated

Agency

FDA (device)