Agency classClass IIOur severity:Severe FDA (Devices)·Z-2564-2014·Announced 2014-09-10

Hitachi Echelon Oval MRI Systems Recalled for Gradient Coil Overheating

Hitachi Medical Systems America Inc is recalling 39 Echelon Oval MRI systems because the gradient coil can overheat and become a burn hazard.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a specific physical hazard (burns) that poses a risk of significant injury, meeting the criteria for a Severe rating.

Plain-English summary

Hitachi Medical Systems America Inc is recalling 39 units of the Hitachi Echelon Oval MRI system. This diagnostic imaging device is intended to provide physicians with physiological and clinical information non-invasively and without ionizing radiation.

The recall was initiated because the Gradient Coil was found to have a failure mode that allows it to overheat, creating a burn hazard. The affected units were distributed worldwide, including in the United States (nationwide, specifically in CA, DE, FL, ID, KS, KY, MD, MS, NY, OH, and WY) and in Japan, Brazil, France, Germany, and Kyrgyzstan.

Healthcare facilities and users should contact Hitachi Medical Systems America Inc for further instructions on how to address the defect. The recall covers specific product codes, including Y001 through Y016, Y101 through Y103, Y105, and Y951.

The recalled product

Product: 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.
Manufacturer: Hitachi Medical Systems America Inc
Category: Medical Device — Imaging Equipment
Hazard: burn-injury
overheating
Affected units: 39

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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.

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Same manufacturer · Hitachi Medical Systems America Inc

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Same hazard · burn injury