| Class 2 Device Recall ECHELON MRI System | |
Date Initiated by Firm | July 29, 2021 |
Create Date | August 24, 2021 |
Recall Status1 |
Terminated 3 on September 08, 2023 |
Recall Number | Z-2337-2021 |
Recall Event ID |
88452 |
510(K)Number | K083533 |
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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Product | ECHELON MRI System |
Code Information |
V001-V070, V952 |
Recalling Firm/ Manufacturer |
Hitachi Healthcare Americas Corporation 1959 Summit Commerce Park Twinsburg OH 44087-2371
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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 |
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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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