| Class 2 Device Recall Hitachi Oasis MRI Coil Extension Cable | |
Date Initiated by Firm | April 25, 2014 |
Date Posted | August 10, 2015 |
Recall Status1 |
Terminated 3 on August 24, 2018 |
Recall Number | Z-2366-2015 |
Recall Event ID |
71431 |
510(K)Number | K072279 |
Product Classification |
Coil, magnetic resonance, specialty - Product Code MOS
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Product | Oasis Coil Extension Cable used with Hitachi Oasis MRI System
Product Usage:
The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. The Coil Extension Cable that is the subject of the removal action is an accessory that is used in conjunction with certain anatomy coils to aid in patient positioning. |
Code Information |
Serial #'s: M001to M108, M110 to M175, M951 & M952. |
Recalling Firm/ Manufacturer |
Hitachi Medical Systems America Inc 1959 Summit Commerce Park Twinsburg OH 44087-2371
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For Additional Information Contact | Mr. Douglas J. Thistlethwaite 330-425-1313 Ext. 3720 |
Manufacturer Reason for Recall | The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Hitachi sent an Urgent: Device Removal Notice letter date April 24, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers to discontinue using the Coil Extension Cable and that a Field Service Engineer will schedule a visit to remove the cable. For questions call 800-800-3106 ext 3720. |
Quantity in Commerce | 173 units |
Distribution | US Nationwide in the states: AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI & WY and the country of Mexico. |
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 = MOS
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