FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1938-2009
- Recalling firm
- Quality Electrodynamics Llc
- 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.
- Status
- Terminated
- Initiated
- 2008-12-29
- Posted
- 2009-09-10
- Terminated
- 2012-04-25
- 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.
- Lot, serial or model codes
- Part Number: Q7000021; Serial Number: 070810, 070811, 100804, 100805, and X110810.
- 510(k) numbers
- K083160
- PMA numbers
- not on file
- Product code
- MOS
- Firm FEI
- 3007350713
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28