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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi Oasis MRI system

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  Class 2 Device Recall Hitachi Oasis MRI system see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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