Recall Z-0429-06 ยท LNH System, Nuclear Magnetic Resonance Imaging
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 syste
| Date | Jan 24, 2006 (initiated Dec 1, 2005) |
| Status | Terminated |
| Reason | The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches. |
| Root cause | Other |
| Action | The recalling firm sent a recall/field correction letter, dated 12/1/05 to all consignees. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974212 | AIRIS II Hitachi Medical Systems America, Inc., Feb 9, 1998 |