Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part #Q7000021, Quality Electrodyn
FDA device recall Z-1938-2009 · posted 2009-09-10 · Terminated
Recall details
- Recalling firm
- Quality Electrodynamics Llc
- Reason for recall
- The firm received a complaint indicating that the mirror is high risk and could drop on a patient.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MOS
- Quantity affected
- 5 units
- Distribution
- Nationwide Distribution: IL and OH.
- Date initiated
- 2008-12-29
- Date posted
- 2009-09-10
- Date terminated
- 2012-04-25
- Location
- Cleveland, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 1.5T ATLAS SPEEDER HEAD-NECK COIL (K083160) | Quality Electrodynamics | 2008-11-07 |