CLASS II Device recall · Reported 29 Mar 2017 · FDA Enforcement Report

Hitachi Echelon MRI System recalled by Hitachi Medical Systems

Hitachi Medical Systems America is recalling Hitachi Echelon MRI System, distributed nationwide in the US. The recall was initiated on 16 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesV001, 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

Quantity recalled68 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1542-2017
FDA event ID: 76373
Recalling firm: Hitachi Medical Systems America, Twinsburg, OH
Classification: Class II
Status: Terminated
Recall initiated: 16 Apr 2015
FDA classified: 23 Mar 2017
Reported: 29 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

16 Apr 2015	Recall initiated by company
23 Mar 2017	Classified by FDA	+707 days
29 Mar 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.

Product as listed by the FDA

Hitachi Echelon MRI System

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Is Hitachi Echelon MRI System recalled?

Yes. Hitachi Medical Systems America recalled Hitachi Echelon MRI System on 16 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1542-2017.

Why was it recalled?

Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.

Which lots 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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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