Recall Z-1028-04 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems Sales & Service Region No. America
Trolley for Intera/NT MRI System
| Date | Jul 20, 2004 (initiated May 13, 2004) |
| Status | Terminated |
| Reason | Patient and MRI tabletop may fall if the tabletop is not positioned correctly on the MRI trolley. |
| Root cause | Other |
| Action | The firm sent a letter via certified mail to all customers on May 13, 2004 instructing their customers to check the position of the tabletop to ensure it is correctly aligned on the trolley. The firm is implementing a design modification beginning May 13, 2004. A field service engineer will contact the customers to arrange for installation of the retrofit for the trolley. |
| Quantity | 57 devices |
| Distribution | Product was distributed to hospitals and medical centers nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.