Recall Z-0786-03 ยท KMI Monitor, Bed Patient
General Electric Medical Systems Information Technology
MAC-LAB (Classic) systems
| Date | Apr 25, 2003 (initiated Apr 14, 2003) |
| Status | Terminated |
| Reason | There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke. |
| Root cause | Other |
| Action | A letter was sent to the consignees on April 14, 2003 and requested that the consignees correct the device or contact the firm to have them perform the correction. |
| Distribution | The recalled products were shipped to hospitals located nationwide in the United States and to other consignees located worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.