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.
Recall
- Recall Number
- Z-2154-2008
- Event Number
- 48467
- Firm
- Datex Ohmeda, Inc. dba GE Healthcare
- FEI Number
- 1121732
- Product Code
- HGM
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- May 5, 2008
- Posted
- August 26, 2008
- Terminated
- August 7, 2012
- Address
- 8880 Gorman Rd, Laurel, MD, 20723-5800
Description
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.
Communication connector within monitor is defective and may cause potential loss of telemetry.
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 1-800-558-7044.
Nationwide Distribution.
133 units