Z-0429-06

The AIRIS II MR System is an imaging device and is intended to provide the physician with physiological and...

Name: Z-0429-06 The AIRIS II MR System is an imaging device and is intended to provide the physician with physiological and...
Creator: Hitachi Medical Systems America Inc
Published: 2005-12-01
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2005-12-01 / Terminated

FDA source

Hitachi Medical Systems America Inc began a recall of The AIRIS II MR System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non invasively and... on 2005-12-01. The reason FDA records is "The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0429-06
Status: Terminated
Initiated: 2005-12-01
Posted: 2006-01-24
Terminated: 2008-10-29
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: The AIRIS II MR System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagital, oblique, and curved cross-sectional images that display the internal structure of the head, body, and extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance and proton density, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.
FDA root cause: Other
Action: The recalling firm sent a recall/field correction letter, dated 12/1/05 to all consignees.
Quantity in commerce: 670 devices.
Distribution: The devices were distributed to FL, WA, IL, TX, NC, NY, OH, CO, LA, NJ, CA, AZ, SC, AR, OK, MN, SD, OR, PA, AL, GA, MD, MS, MO, CT, WI, KY, IN, KS, MA, DE, IA, UT, TN, VA, ID, NE, ND, NV, Puerto Rico, and to St. Thomas, Virgin Islands.
Product codes and lots: Serial numbers C048 thru C788.

Product code LNH

K974212Class IIAiris IIHitachi Medical Systems America, Inc. / cleared 1998-02-09

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)