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.
FDA Recall Z-0429-06 · Posted 2006-01-24
Advertisement
Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2005-12-01
Date Terminated2008-10-29
Product Quantity670 devices.
Reason for Recall
The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.
Firm Action
The recalling firm sent a recall/field correction letter, dated 12/1/05 to all consignees.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement