Hitachi Healthcare Americas Corporation Recall 88452
Description: OASIS MRI System
Hitachi Healthcare Americas Corporation Recall 88452 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2339-2021 |
| Event ID | 88452 |
| Event Description | OASIS MRI System |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Mexico and Brazil. |
| Quantity | 472 (US); 10 (OUS) Total |
| Recall 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 Code of Federal Regulations section 21CFR801.437. |
| Device Classification | 20210901 |
| Device Code Info | M001-M329, M951 |
| Center Classification Date | 20210824 |
| Recall Initiation Date | 20210729 |
| Recalling Firm | Hitachi Healthcare Americas Corporation |
| Initial Notification | Letter |
| Similar To |