Recall Z-2479-2018 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hitachi Medical Systems America Inc
Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the head, body, or extremitie
| Date | Jun 18, 2018 |
| Status | Terminated |
| Reason | The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. The firm has received two complaints where technologists have cut their fingers on this belt. |
| Root cause | Device Design |
| Action | On June 18, 2018, the firm distributed an Urgent Medical Device Correction Notices to affected customers. Customers were informed of the issue and advised that the firm would be adding protective guards to both sides of the belt to prevent accidental contact. The firm expects to begin installing the guards around fall 2018. In the meantime, customers are advised to avoid direct contact with the stainless steel belt. Questions, comments, or requests may be sent to recalls@hitachihealthcare.com. |
| Quantity | 264 |
| Distribution | Worldwide Distribution - US Nationwide distribution.in the states of Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093044 | OASIS MRI SYSTEM Hitachi Medical Systems America, Inc., Mar 16, 2010 |