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.
This recall has been terminated (originally issued August 23, 2008).
- Recall Initiated
- February 11, 2008
- Posted
- August 23, 2008
- Terminated
- September 24, 2010
- Recall Number
- Z-1542-2008
- Quantity
- 235 units
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
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.
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
Lot / Code Info
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.
Root Cause
Component design/selection
Action Taken
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.