GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is
This recall has been terminated (originally issued September 23, 2003).
- Recall Initiated
- May 21, 2003
- Posted
- September 23, 2003
- Terminated
- October 27, 2003
- Recall Number
- Z-1291-03
- Quantity
- 170
- Firm Location
- Tampa, FL
- Official Source
- View on FDA website ↗
Reason for Recall
The 2120 Main Board on device lacks required external safety 'watchdog' circuit.
Distribution
The monitors were distributed to 8 hospitals in SC, WI, CA, MN, TX, MD and NV, as well as two hospitals in France.
Lot / Code Info
All serial numbers are involved.
Root Cause
Other
Action Taken
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.
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