Z-2339-2021Class II

OASIS MRI System

Name: Z-2339-2021 OASIS MRI System
Creator: Hitachi Healthcare Americas Corporation
Published: 2021-07-29
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2021-07-29 / Terminated / root cause: supplier

FDA source

Hitachi Healthcare Americas Corporation began a recall of OASIS MRI System on 2021-07-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2339-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-29
Posted: 2021-08-24
Terminated: 2023-09-08
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: OASIS MRI System
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: 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.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: On July 29, 2021, the firm distributed Urgent Medical Device Safety Alert letters to affected customers. Customers were informed that the anti-skid area on the bottom of the table pads contain dry natural rubber. If a patient or user inadvertently comes into contact with the anti-skid material, it may cause allergic symptoms. If this occurs, immediately seek medical care for the user or patient. The firm does not require any additional action by the user at this time. The firm will begin including revised labels and user manuals with newly manufactured systems which contain the required notification of the presence of dry natural rubber in the anti-skid area of the pads. The firm will not be taking any additional action for already distributed product. For questions, comments, or concerns, please contact: Aaron Pierce Director, QA/RA 1959 Summit Commerce Park Twinsburg, OH 44087 Phone (330) 425-1313 x2934, Fax (330) 963-0749 Email [email protected]
Quantity in commerce: 472 (US); 10 (OUS) Total
Distribution: Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
Product codes and lots: M001-M329, M951

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2339-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2337-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-24
Z-2338-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-24
Z-2339-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-24

Product code LNH

K202030Class IIOASIS MRI SystemHitachi Healthcare Americas / cleared 2020-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)