Recall Z-2339-2021 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hitachi Healthcare Americas Corporation
OASIS MRI System
| Date | Jul 29, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Vendor change control |
| Action | On July 29, 2021, the firm distributed Urgent Medical Device Safety Alert letters to affected customers. Customers were informed that the anti-skid area on the bottom of the table pads contain dry natural rubber. If a patient or user inadvertently comes into contact with the anti-skid material, it may cause allergic symptoms. If this occurs, immediately seek medical care for the user or patient. The firm does not require any additional action by the user at this time. The firm will begin including revised labels and user manuals with newly manufactured systems which contain the required noti |
| Quantity | 472 (US); 10 (OUS) Total |
| Distribution | Worldwide distribution - US Nationwide and the countries of Mexico and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202030 | OASIS MRI System Hitachi Healthcare Americas, Oct 21, 2020 |