Hitachi Medical Systems America Inc 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 N Recall
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According to the U.S. Food and Drug Administration (FDA)
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 N
Brand
Hitachi Medical Systems America Inc
Lot Codes / Batch Numbers
Serial numbers C048 thru C788.
Products Sold
Serial numbers C048 thru C788.
Hitachi Medical Systems America Inc is recalling The AIRIS II MR System is an imaging device and is intended to provide the physician with physiologi due to The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.
Recommended Action
Per FDA guidance
The recalling firm sent a recall/field correction letter, dated 12/1/05 to all consignees.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, PR
Page updated: Jan 10, 2026