Recall Z-1616-2010 ยท MOS Coil, Magnetic Resonance, Specialty
Hitachi Medical Systems America Inc
Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO
| Date | May 19, 2010 (initiated Apr 19, 2010) |
| Status | Terminated |
| Reason | Hitachi determined that the mounting method for a Compensation Coil did not include an appropriate factor of safety, so it is possible that the coil could fall, contacting the patient table and potentially putting a patient at risk. |
| Root cause | Other |
| Action | On 4/15/2010 the firm sent Device Correction Notice letters to their customers identifying the affected product and informing them of the potential problem. The letter stated that the firm will change the coil mounting method used at the customer's facility, if necessary, at no cost to the customer. A service rep will contact them to schedule a visit to correct the problem. |
| Quantity | 56 devices |
| Distribution | Nationwide Distribution -- AL, AR, AZ, CA, CT, DC, DE, FL, ID, IL, IN, KY, LA, MD, MO, NJ, NY, OH, OK, OR, RI, TN, TX, VA & WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001334 | HITACHI AIRIS II Hitachi Medical Systems America, Inc., Jul 6, 2000 |