Hitachi Healthcare recalls specific ECHEL:ON Oval MRI systems due to missing label indicating dry natural rubber pads, which may not meet federal safety regulations.
There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.
Hitachi Healthcare is recalling certain ECHELON Oval MRI systems because the table pads contain dry natural rubber that wasn't properly labeled. This could violate federal safety regulations and might not be safe for use.
The dry natural rubber pads in the table may not meet federal safety regulations because the label indicating their composition was missing. This could lead to regulatory non-compliance but does not pose an immediate risk of injury during normal use.
Users of the recalled ECHELON Oval MRI systems, particularly those in medical facilities that use the equipment for imaging. Medical staff and patients are at risk if the unlabeled pads cause issues.
Check for ECHELON Oval MRI systems with model numbers Y001-Y016, Y051-Y068, Y101-Y169, or Y951. The missing label on the pad packaging or user manual is the key indicator of the recall.
Look for a label on the pad packaging or user manual indicating the presence of dry natural rubber.
The recall is happening because the table pads contain dry natural rubber that wasn't properly labeled, which may violate federal safety regulations.
Check for the missing label on the pad packaging or user manual. If you find the label missing, contact Hitachi Healthcare for guidance.
The missing label does not pose an immediate risk of injury during normal use but could lead to regulatory non-compliance.
We’ve drafted a message you can send Hitachi Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2338-2021 — Hitachi Healthcare Hitachi Healthcare Hello, I own a Hitachi Healthcare that is covered by recall Z-2338-2021 from Hitachi Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
