Summary
The FDA issued a Class II for ECHELON Oval MRI System by Hitachi Healthcare Americas Corporation. Reason: 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 .
Details
Source
Device Recall
External ID
Z-2338-2021
Action Date
2021-09-01
Status
Terminated
Category
device
Product Description
ECHELON Oval MRI System
Lot/Code Info: Y001-Y016, Y051-Y068, Y101-Y169, Y951
Quantity Affected: 472 (US); 10 (OUS) Total
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-29
Company
Twinsburg, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hitachi Healthcare Americas Corporation has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hitachi Healthcare Americas Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hitachi Healthcare Americas Corporation have FDA actions?
Hitachi Healthcare Americas Corporation has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2338-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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