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Terminated

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.

FDA Recall Z-1938-2009 · Posted 2009-09-10

Recalling FirmQuality Electrodynamics Llc
Recall StatusTerminated
Product CodeMOS
Date Initiated2008-12-29
Date Terminated2012-04-25
Product Quantity5 units

Reason for Recall

The firm received a complaint indicating that the mirror is high risk and could drop on a patient.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution: IL and OH.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0831601.5T ATLAS SPEEDER HEAD-NECK COILQuality Electrodynamics · 2008-11-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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