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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- 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
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