ECHELON Oval MRI System
Reported: September 1, 2021 Initiated: July 29, 2021 #Z-2338-2021
Product Description
ECHELON Oval MRI System
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.
Details
- Recalling Firm
- Hitachi Healthcare Americas Corporation
- Units Affected
- 472 (US); 10 (OUS) Total
- Distribution
- Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
- Location
- Twinsburg, OH
Frequently Asked Questions
What product was recalled? ▼
ECHELON Oval MRI System. Recalled by Hitachi Healthcare Americas Corporation. Units affected: 472 (US); 10 (OUS) Total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 1, 2021. Severity: Moderate. Recall number: Z-2338-2021.
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