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Class 2 Device Recall Altaire MRI System |
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Date Initiated by Firm |
February 11, 2008 |
Date Posted |
August 23, 2008 |
Recall Status1 |
Terminated 3 on September 24, 2010 |
Recall Number |
Z-1542-2008 |
Recall Event ID |
47252 |
510(K)Number |
K002420
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Product Classification |
System, Nuclear Magnetic Resonance Imaging - Product Code LNH
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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.
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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 OH 44087-2371
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For Additional Information Contact |
Douglas J. Thistlethwaite 800-800-3106 Ext. 3720
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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.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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