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U.S. Department of Health and Human Services

Class 2 Device Recall Mirror assembly to 1.5T Atlas SPEEDER HeadNeck Coil

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 Class 2 Device Recall Mirror assembly to 1.5T Atlas SPEEDER HeadNeck Coilsee related information
Date Initiated by FirmDecember 29, 2008
Date PostedSeptember 10, 2009
Recall Status1 Terminated 3 on April 25, 2012
Recall NumberZ-1938-2009
Recall Event ID 51281
510(K)NumberK083160 
Product Classification Coil, magnetic resonance, specialty - Product Code MOS
ProductMirror 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.
Code Information Part Number: Q7000021; Serial Number: 070810, 070811, 100804, 100805, and X110810.
FEI Number 3007350713
Recalling Firm/
Manufacturer		 Quality Electrodynamics Llc
777 Beta Dr
Cleveland OH 44143-2336
For Additional Information ContactChristie Zydyk
440-484-2228
Manufacturer Reason
for Recall		The firm received a complaint indicating that the mirror is high risk and could drop on a patient.
FDA Determined
Cause 2		Device Design
ActionQuality 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 Commerce5 units
DistributionNationwide Distribution: IL and OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MOS
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