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U.S. Department of Health and Human Services

Class 2 Device Recall ECHELON Oval MRI System

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  Class 2 Device Recall ECHELON Oval MRI System see related information
Date Initiated by Firm July 29, 2021
Create Date August 24, 2021
Recall Status1 Terminated 3 on September 08, 2023
Recall Number Z-2338-2021
Recall Event ID 88452
510(K)Number K172110  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product ECHELON Oval MRI System
Code Information Y001-Y016, Y051-Y068, Y101-Y169, Y951
Recalling Firm/
Manufacturer		 Hitachi Healthcare Americas Corporation
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact Aaron J. Pierce
330-425-1313 Ext. 3720
Manufacturer Reason
for Recall		 There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.
FDA Determined
Cause 2		 Vendor change control
Action On July 29, 2021, the firm distributed Urgent Medical Device Safety Alert letters to affected customers. Customers were informed that the anti-skid area on the bottom of the table pads contain dry natural rubber. If a patient or user inadvertently comes into contact with the anti-skid material, it may cause allergic symptoms. If this occurs, immediately seek medical care for the user or patient. The firm does not require any additional action by the user at this time. The firm will begin including revised labels and user manuals with newly manufactured systems which contain the required notification of the presence of dry natural rubber in the anti-skid area of the pads. The firm will not be taking any additional action for already distributed product. For questions, comments, or concerns, please contact: Aaron Pierce Director, QA/RA 1959 Summit Commerce Park Twinsburg, OH 44087 Phone (330) 425-1313 x2934, Fax (330) 963-0749 Email aaron.pierce@fujifilm.com
Quantity in Commerce 472 (US); 10 (OUS) Total
Distribution Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
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 Healthcare Americas Corporation
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