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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner

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 Class 2 Device Recall Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scannersee related information
Date Initiated by FirmApril 19, 2010
Date PostedMay 19, 2010
Recall Status1 Terminated 3 on September 21, 2012
Recall NumberZ-1616-2010
Recall Event ID 55555
510(K)NumberK001334 
Product Classification Magnetic Resonance Specialty Coil - Product Code MOS
ProductHitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO
Code Information Part numbers: MR-FC-2EO, MR-FC-3EO
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087
For Additional Information Contact
330-425-1313 Ext. 3720
Manufacturer Reason
for Recall		Hitachi determined that the mounting method for a Compensation Coil did not include an appropriate factor of safety, so it is possible that the coil could fall, contacting the patient table and potentially putting a patient at risk.
FDA Determined
Cause 2		Other
ActionOn 4/15/2010 the firm sent Device Correction Notice letters to their customers identifying the affected product and informing them of the potential problem. The letter stated that the firm will change the coil mounting method used at the customer's facility, if necessary, at no cost to the customer. A service rep will contact them to schedule a visit to correct the problem.
Quantity in Commerce56 devices
DistributionNationwide Distribution -- AL, AR, AZ, CA, CT, DC, DE, FL, ID, IL, IN, KY, LA, MD, MO, NJ, NY, OH, OK, OR, RI, TN, TX, VA & WA.
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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