Reported Mar 29, 2017 · Terminated
Hitachi Echelon MRI System
Hitachi Medical Systems America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hitachi Medical Systems America Inc · 1959 Summit Commerce Park · Twinsburg, OH · 44087-2371
Is this the product you have?
- Hitachi Echelon MRI System
- Lot codes and dates
68 of 68 codes
V001V002V003V004V005V006V007V008V009V010V011V012V013V014V015V016V017V018V020V021V022V023V024V025V026V027V028V029V030V031V032V033V034V035V036V037V038V039V040V041V042V043V044V045V046V047V048V049V050V051V052V053V054V055V056V057V058V059V060V061
- Amount recalled
- 68 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Hitachi Medical Systems America Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.