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.
FDA Recall Z-2154-2008 · Posted 2008-08-26
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Recalling FirmDatex Ohmeda, Inc. dba GE Healthcare
Recall StatusTerminated
Product CodeHGM
Date Initiated2008-05-05
Date Terminated2012-08-07
Product Quantity133 units
Reason for Recall
Communication connector within monitor is defective and may cause potential loss of telemetry.
Firm 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 1-800-558-7044.
Root Cause
Component design/selection
Distribution Pattern
Nationwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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