Z-1938-2009

Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part #Q7000021, Quality...

Name: Z-1938-2009 Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part #Q7000021, Quality...
Creator: Quality Electrodynamics Llc
Published: 2008-12-29
License: https://open.fda.gov/license/

Quality Electrodynamics / initiated 2008-12-29 / Terminated / root cause: design

FDA source

Quality Electrodynamics Llc began a recall of Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part #Q7000021, Quality Electrodynamics, Mayfield Village, OH 44143. The... on 2008-12-29. The reason FDA records is "The firm received a complaint indicating that the mirror is high risk and could drop on a patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1938-2009
Status: Terminated
Initiated: 2008-12-29
Posted: 2009-09-10
Terminated: 2012-04-25
Recalling firm: Quality Electrodynamics
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.
Product code: MOS Coil, Magnetic Resonance, Specialty
Reason for recall: The firm received a complaint indicating that the mirror is high risk and could drop on a patient.
Root cause tag: design
FDA 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 in commerce: 5 units
Distribution: Nationwide Distribution: IL and OH.
Product codes and lots: Part Number: Q7000021; Serial Number: 070810, 070811, 100804, 100805, and X110810.

Product code MOS

K083160Class II1.5T Atlas Speeder Head-Neck CoilQuality Electrodynamics / cleared 2008-11-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)