CLASS II Device recall · Reported 10 Sep 2014 · FDA Enforcement Report

Hitachi Echelon Oval MRI system is a diagnostic imaging recalled

Hitachi Medical Systems America is recalling Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and, distributed nationwide in the US. The recall was initiated on 18 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Codes: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y014, Y015, Y016, Y101, Y102, Y103, Y105, and Y951. To be updated as firm submits information.

Quantity recalled39 systems

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-2564-2014
FDA event ID: 68758
Recalling firm: Hitachi Medical Systems America, Twinsburg, OH
Classification: Class II
Status: Terminated
Recall initiated: 18 Aug 2014
FDA classified: 2 Sep 2014
Reported: 10 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Imaging Equipment

Timeline

18 Aug 2014	Recall initiated by company
2 Sep 2014	Classified by FDA	+15 days
10 Sep 2014	Published in enforcement report	+8 days

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

Reason for recall

The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.

Where it was distributed

Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, ID, KS, KY, MD, MS, NY, OH, and WY; countries of: Japan, Brazil, France, Germany, and Kyrgyzstan.

Nationwide California Delaware Florida Idaho Kansas Kentucky Maryland Mississippi New York Ohio Wyoming

Questions about this recall

Is Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and recalled?

Yes. Hitachi Medical Systems America recalled Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and on 18 Aug 2014. The recall is Class II and its status is Terminated. Recall number Z-2564-2014.

Why was it recalled?

The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.

Which lots are affected?

Product Codes: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y014, Y015, Y016, Y101, Y102, Y103, Y105, and Y951. To be updated as firm submits information.

Where was it sold?

Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, ID, KS, KY, MD, MS, NY, OH, and WY; countries of: Japan, Brazil, France, Germany, and Kyrgyzstan.

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.

More recalls from Hitachi Medical Systems America

All 17

Reported	Class	Recall	Company	Reason	Where
31 Mar 2021Device	CLASS II	Ultrasonic pulsed doppler imaging system recalled	Hitachi Medical Systems America	Potency & Assay	Nationwide
26 Feb 2020Device	CLASS II	UST-2265-2 Probe recalled by Hitachi Medical Systems	Hitachi Medical Systems America	Other	8 states
13 Nov 2019Device	CLASS II	Hitachi Scenaria Whole-body X-ray CT System recalled	Hitachi Medical Systems America	Device Malfunction	16 states
29 Aug 2018Device	CLASS II	Hitachi Scenaria CT system recalled by Hitachi Medical Systems	Hitachi Medical Systems America	Device Malfunction	TX
25 Jul 2018Device	CLASS II	Hitachi Oasis MRI system recalled by Hitachi Medical Systems	Hitachi Medical Systems America	Foreign Material	Nationwide

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled	Canon Medical System, USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Lead & Heavy Metals