Hitachi Healthcare recalls OAS: MRI systems M001-M329 and M951 due to missing label indicating dry natural rubber pads, which may not meet federal safety standards.
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 OASIS MRI systems with model numbers M001-M329 and M9:51 because the table pads contain dry natural rubber that requires a specific label per federal regulations. This could lead to safety issues if the label is missing.
The table pads in these MRI systems contain dry natural rubber, which must be labeled according to federal regulations. Without this label, the system might not meet safety standards, potentially causing issues during MRI procedures.
Medical facilities using the OASIS MRI systems with model numbers M001-M329 or M951 are most at risk. Patients and staff could be affected if the missing label causes safety issues during MRI procedures.
Check the model numbers on the OASIS MRI system: M001-M329 or M951. The missing label on the pad packaging or user manual is the key indicator of the recall.
Look for model numbers M001-M329 or M951 on the OASIS MRI system.
The OASIS MRI systems with model numbers M001-M329 and M951 are being recalled because the table pads contain dry natural rubber that requires a specific label per federal regulations, but the label is missing.
Check the model numbers on your OASIS MRI system. If it is M001-M329 or M951, contact Hitachi Healthcare for further instructions.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Hitachi Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2339-2021 — Hitachi Healthcare Hitachi Healthcare Hello, I own a Hitachi Healthcare that is covered by recall Z-2339-2021 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.
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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.
