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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi Altaire Magnetic Resonance Imaging Device

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  Class 2 Device Recall Hitachi Altaire Magnetic Resonance Imaging Device see related information
Date Initiated by Firm January 27, 2006
Date Posted June 10, 2006
Recall Status1 Terminated 3 on November 13, 2008
Recall Number Z-1103-06
Recall Event ID 34856
510(K)Number K022390  K002420  
Product Classification MRI Magnetic Resonance Imaging - Product Code LNH
Product Hitachi Altaire Magnetic Resonance Imaging System
Code Information L001 thru L223.
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact Douglas J. Thistlethwaite
330-425-1313
Manufacturer Reason
for Recall		 Circuit Failure-There is the potential risk of the Phase Loss Detector Safety Device (PHSEN PCB) malfunctioning in the event of a power loss. The circuit may fail to turn off the system main breaker when 2 of the 3 power phases are lost.
FDA Determined
Cause 2		 Other
Action The recalling firm sent a Device Correction Letter dated 1/27/06 to all of their customers. The letter informs the customers of the problem in the (PHSEN PCB) and notifies the customers that an HMSA Field Service Technician will be performing a PCB modification to the unit, on-site, during their next scheduled preventative maintenance visit. Should the customer wish to have the modification performed prior to the representative''s scheduled visit, the letter says that they can telephone their local Field Service Rep. and make arrangements to have the modification performed at their convenience.
Quantity in Commerce 213 devices have been distributed and installed.
Distribution Nationwide-The device was distributed to consignees located throughout the United States.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LNH and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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