| Class 2 Device Recall Hitachi Oasis MRI system | |
Date Initiated by Firm | June 18, 2018 |
Create Date | July 18, 2018 |
Recall Status1 |
Terminated 3 on April 20, 2020 |
Recall Number | Z-2479-2018 |
Recall Event ID |
80464 |
510(K)Number | K093044 |
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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Product | Hitachi Oasis MRI system
Product Usage:
Hitachi 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 crosssectional 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. |
Code Information |
M001 to M028, M030 to M108, M110 to M266, 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. Thistlethwaithe 330-425-1313 Ext. 3720 |
Manufacturer Reason for Recall | The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. The firm has received two complaints where technologists have cut their fingers on this belt. |
FDA Determined Cause 2 | Device Design |
Action | On June 18, 2018, the firm distributed an Urgent Medical Device Correction Notices to affected customers. Customers were informed of the issue and advised that the firm would be adding protective guards to both sides of the belt to prevent accidental contact. The firm expects to begin installing the guards around fall 2018.
In the meantime, customers are advised to avoid direct contact with the stainless steel belt.
Questions, comments, or requests may be sent to recalls@hitachihealthcare.com. |
Quantity in Commerce | 264 |
Distribution | Worldwide Distribution - US Nationwide distribution.in the states 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 = LNH
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