GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is
FDA Recall Z-1291-03 · Posted 2003-09-23
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Recalling FirmGE Medical Systems Information Technologies
Recall StatusTerminated
Product CodeHGM
Date Initiated2003-05-21
Date Terminated2003-10-27
Product Quantity170
Reason for Recall
The 2120 Main Board on device lacks required external safety 'watchdog' circuit.
Firm Action
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.
Root Cause
Other
Distribution Pattern
The monitors were distributed to 8 hospitals in SC, WI, CA, MN, TX, MD and NV, as well as two hospitals in France.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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