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U.S. Department of Health and Human Services

Class 2 Device Recall Altaire MRI System

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 Class 2 Recall
Altaire MRI System
see related information
Date Posted August 23, 2008
Recall Status1 Terminated on September 24, 2010
Recall Number Z-1542-2008
Recall Event ID 47252
Premarket Notification
510(K) Number
K002420 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physician with physiological and clinical information obtained non-invasive and without the use of ionizing radiation.
Code Information Units were distributed nationwide from 05/23/2001 to 12/07/2007. If you have questions concerning this action, contact Douglas J. Thistlethwaite at (800) 800-3106 x3720.
Recalling Firm/
Manufacturer
Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg, Ohio 44087-2371
Consumer Instructions Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.
For Additional Information Contact Douglas J. Thistlethwaite
800-800-3106 Ext. 3720
Manufacturer Reason
for Recall
The firm's Altaire MR Scanner's Emergency Rundown Switch Unit (ERDU), that is used to shut down the device in an emergency, was found to be defective. An ERDU failure could delay or prevent patient access leading to possible patient death or serious injury.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action The firm issue a DEVICE CORRECTION letter to their customers on 2/11/2008. The letter informs the customers of the Emergency Rundown Switch Unit (ERDU) defect and provides a warning which lists instructions for the safe use of the ERDU Unit. The letter informs the customer(s) that their local Hitachi Field Service Engineer (FSE) will be scheduling a visit to test the ERDU in order to verify its state of operation. The letter also states that This test requires specific tools in order to verify the operation without actually quenching the magnet and that Hitachi will begin the test ING in March, 2008 and will continue the program until all installed ERDU units are verified. Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.
Quantity in Commerce 235 units
Distribution The recalled device units were distributed to customers located in the following states nationwide: CA, OH, IL, NJ, NY, FL, TX, NE, AR, MD, OR, MN, NV, MS, OK, IN, TN, MO, SC, VA, HI, LA, NC, NM, WY, WA, AL, PA, UT, WA, and KY
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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