Recall Z-2154-2008 ยท HGM System, Monitoring, Perinatal
Datex Ohmeda, Inc. dba GE Healthcare
Corometrics MODEL 250 Series Maternal/ Fetal Monitor, Models 256 and 259, part number 2024489-002. Intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms; maternal uterine activity; heart/pulse rate, blood pressure and %SP02.
| Date | Aug 26, 2008 (initiated May 5, 2008) |
| Status | Terminated |
| Reason | Communication connector within monitor is defective and may cause potential loss of telemetry. |
| Root cause | Component design/selection |
| Action | The recalling firm notified healthcare professionals by an Urgent Medical Device Correction letter dated 07/01/2008 to Healthcare Administrators, Risk Managers, Nurse Managers and Directors of Clinical Engineering. The letter advised of a defect in a communication board that may cause a potential loss of telemetry monitoring. The firm recommended that the device should not be used with the firm's 340 Series telemetry system pending replacement of the defective board by service engineers. The Healthcare Professionals are asked to contact the GE Healthcare Technical Support center at 1-800-558- |
| Quantity | 133 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.