Recall Z-1291-03 ยท HGM System, Monitoring, Perinatal
GE Medical Systems Information Technologies
GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is
| Date | Sep 23, 2003 (initiated May 21, 2003) |
| Status | Terminated |
| Reason | The 2120 Main Board on device lacks required external safety 'watchdog' circuit. |
| Root cause | Other |
| Action | The firm mailed or faxed a recall letter to consignees on May 14, 2003 followed by a phone call to each account within two weeks to arrange for a service technician visit to correct the monitors. The recall letter warned the hospitals of the problem and a work around. |
| Quantity | 170 |
| Distribution | The monitors were distributed to 8 hospitals in SC, WI, CA, MN, TX, MD and NV, as well as two hospitals in France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021135 | MODEL 2120IS SERIES MATERNAL/FETAL MONITOR Ge Medical Systems Information Technologies, May 9, 2002 |