Corometrics MODEL 250 Series Maternal/ Fetal Monitor, Models 256 and 259, part number 2024489-002. Intended for monitori
FDA device recall Z-2154-2008 · posted 2008-08-26 · Terminated
Recall details
- Recalling firm
- Datex Ohmeda, Inc. dba GE Healthcare
- Reason for recall
- Communication connector within monitor is defective and may cause potential loss of telemetry.
- Action taken
- 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
- Status
- Terminated
- Product code
- HGM
- Quantity affected
- 133 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-05-05
- Date posted
- 2008-08-26
- Date terminated
- 2012-08-07
- Location
- Laurel, MD
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