Recall Z-1938-2009
Quality Electrodynamics Llc · initiated December 29, 2008
Product
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.
Codes / lots: Part Number: Q7000021; Serial Number: 070810, 070811, 100804, 100805, and X110810.
Reason for recall
The firm received a complaint indicating that the mirror is high risk and could drop on a patient.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-1938-2009
- Initiated
- December 29, 2008
- Posted by FDA
- September 10, 2009
- Terminated
- April 25, 2012
- Product code
- MOS – Coil, Magnetic Resonance, Specialty
- Quantity
- 5 units
- Distribution
- Nationwide Distribution: IL and OH.
- Recalling firm
- Quality Electrodynamics Llc, Cleveland, OH