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.
- Recall Initiated
- December 1, 2005
- Posted
- January 24, 2006
- Terminated
- October 29, 2008
- Recall Number
- Z-0429-06
- Quantity
- 670 devices.
- Firm Location
- Twinsburg, OH
Reason for Recall
The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.
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.
Lot / Code Info
Serial numbers C048 thru C788.
Root Cause
Other
Action Taken
The recalling firm sent a recall/field correction letter, dated 12/1/05 to all consignees.
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