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U.S. Department of Health and Human Services

Class 2 Device Recall Altaire

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  Class 2 Device Recall Altaire see related information
Date Initiated by Firm November 18, 2004
Date Posted May 17, 2005
Recall Status1 Terminated 3 on January 04, 2008
Recall Number Z-0846-05
Recall Event ID 31772
510(K)Number K022390  K002420  
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Altaire, Magnetic Resonance Imaging Device.
Code Information Serial numbers: L001 to L191.
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1995 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact Doug Thistlethwaite
330-425-1313
Manufacturer Reason
for Recall		 The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor.
FDA Determined
Cause 2		 Other
Action The firm implemented site inspections of customers beginning on 11/19/04 which have been completed. Customers that had the suspect component had it replaced.
Quantity in Commerce 189 devices
Distribution Direct accounts located in AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
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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