Recall Z-1542-2008 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hitachi Medical Systems America Inc
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.
| Date | Aug 23, 2008 (initiated Feb 11, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 M |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002420 | HITACHI ALTAIRE Hitachi Medical Systems America, Inc., Oct 17, 2000 |