Lower riskMedical device recall · FDA · Published July 29, 2021
Hitachi OASIS MRI System Recall: Missing Dry Natural Rubber Label
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 OASIS MRI System Recall: Missing Dry Natural Rubber Label.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62122-hitachi-oasis-mri-system-recall-missing-dry-natural-rubber-label. Based on FDA recall #Z-2339-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2339-2021%22&limit=1).
Hitachi Healthcare Americas Corporation voluntarily recalled OASIS MRI Systems on July 29, 2021, according to the FDA. The recall addresses missing labels on pad packaging that failed to notify users of dry natural rubber content. The agency announced the Class II recall, which has since been terminated.
How to tell if you have it
Brand: Hitachi Healthcare
Product: OASIS MRI System
Model numbers: M001-M329, M951
The hazard
The FDA stated that there was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber. This omission violates Code of Federal Regulations section 21CFR801.437.
Context
GovInfoNow's records show Hitachi Healthcare Americas Corporation has one other recall on record since June 30, 2021, specifically the June 30, 2021 L43K Intraoperative Probe Recall regarding screw covers. Other recent recalls of similar products include the August 18, 2026 Baxter Healthcare PRO+ 40" MRS SURFACE Mattress Recall and the December 3, 2025 Philips Ingenia Elition S MRI Systems Recall.
How to tell if you have this one
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.
Brand
Hitachi Healthcare
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
Look for model numbers M001-M329 or M951 on the OASIS MRI system.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2339-2021 (July 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2339-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.