Recall Z-1938-2009 ยท MOS Coil, Magnetic Resonance, Specialty
Quality Electrodynamics Llc
Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part #Q7000021, Quality Electrodynamics, Mayfield Village, OH 44143. The indications for use are routine MR imaging.
| Date | Sep 10, 2009 (initiated Dec 29, 2008) |
| Status | Terminated |
| Reason | The firm received a complaint indicating that the mirror is high risk and could drop on a patient. |
| Root cause | Device Design |
| Action | Quality Electrodynamics, LLC notified Customers via email beginning December 29, 2008 requesting the affected device be returned to the firm for improvement. For further information, contact Quality Electrodynamics, LLC at 1-440-484-2228. |
| Quantity | 5 units |
| Distribution | Nationwide Distribution: IL and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083160 | 1.5T ATLAS SPEEDER HEAD-NECK COIL Quality Electrodynamics, Nov 7, 2008 |