Hitachi Healthcare recalls ECHELON MRI systems (V001-V070, V952) due to missing label indicating dry natural rubber pads, which may not meet 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 ECHEL:ON MRI systems with serial numbers V001-V070 and V952 because the table pads contain dry natural rubber that requires a specific label under federal regulations. This could lead to safety issues if the label is missing.
The table pads contain dry natural rubber that must be labeled per federal regulations. Without this label, the pads might not meet safety standards, potentially causing issues during MRI procedures.
Medical facilities using the ECHELON MRI systems with serial numbers V001-V070 or V952 are likely affected. Staff handling the table pads may be at risk if the label is missing.
Check the serial number on the ECHELON MRI system. The affected models are V001-V070 and V952. The missing label on the pad packaging or user manual is the key indicator.
Identify the serial number on the ECHELON MRI system to confirm if it falls within V001-V070 or V952.
The recall occurs because the table pads contain dry natural rubber that requires a label under federal regulations, but the label is missing.
Check the serial number to see if it's affected (V001-V070 or V952). If so, contact Hitachi Healthcare for further instructions.
The recall is for regulatory compliance, not a direct safety hazard. The risk is low as it relates to labeling requirements rather than immediate injury.
We’ve drafted a message you can send Hitachi Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2337-2021 — Hitachi Healthcare Hitachi Healthcare Hello, I own a Hitachi Healthcare that is covered by recall Z-2337-2021 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.
