Product Safety Recalls

Product Recall Tracker

Hitachi Healthcare Americas Corporation Recall 88452

Description: ECHELON MRI System

Hitachi Healthcare Americas Corporation Recall 88452 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2337-2021
Event ID88452
Event DescriptionECHELON MRI System
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Mexico and Brazil.
Quantity472 (US); 10 (OUS) total
Recall ReasonThere 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.
Device Classification20210901
Device Code InfoV001-V070, V952
Center Classification Date20210824
Recall Initiation Date20210729
Recalling FirmHitachi Healthcare Americas Corporation
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.