Recall Z-0092-04 ยท DSI Detector And Alarm, Arrhythmia
General Electric Medical Systems Information Technology
Solar 8000M Patient Monitor with software versions 3A, 3B and 3C
| Date | Nov 6, 2003 (initiated Jun 14, 2002) |
| Status | Terminated |
| Reason | Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display, and selected gain settings for a selected waveform. |
| Root cause | Other |
| Action | A 'Patient Safety Alert' letter dated June 14, 2002 was sent to the consignees. The letter recommended certain actions to avoid the problems and stated that the firm''s field service team would contact the consignees to schedule a software revision to eliminate the problem. |
| Quantity | 2809 monitors and 238 software update kits |
| Distribution | The devices were distributed nationwide in the United States and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.