Product Safety Recalls

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Hitachi Healthcare Americas Corporation Recall 88452

Description: ECHELON MRI System

Hitachi Healthcare Americas Corporation Recall 88452 Information

StatusOngoing
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
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