Recall Z-0250-04 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
General Electric Medical Systems Information Technology
Solar 9500 Information Monitor with software version 3A.
| Date | Dec 18, 2003 (initiated Nov 10, 2003) |
| Status | Terminated |
| Reason | Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first. |
| Root cause | Other |
| Action | A letter dated November 10, 2003 was sent to the consignees. The letter recommended certain actions to avoid the problems and provided options for the software to be updated. |
| Quantity | maximum 648 Solar 9500s with Version 3A software (297 Solar 9500 Vers. 3A software were manufactured plus 131 software u |
| Distribution | The product was distributed to consignees located nationwide in the United States and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030575 | MODIFICATION TO SOLAR 9500 INFORMATION MONITOR Ge Medical Systems Information Technologies, Mar 21, 2003 |