Z-1291-03

GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is

Name: Z-1291-03 GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is
Creator: GE Medical Systems Information Technologies
Published: 2003-05-21
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2003-05-21 / Terminated

FDA source

GE Medical Systems Information Technologies began a recall of GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is on 2003-05-21. The reason FDA records is "The 2120 Main Board on device lacks required external safety 'watchdog' circuit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1291-03
Status: Terminated
Initiated: 2003-05-21
Posted: 2003-09-23
Terminated: 2003-10-27
Recalling firm: GE Medical Systems Information Technologies, Inc.
Product: GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is
Product code: HGM System, Monitoring, Perinatal
Reason for recall: The 2120 Main Board on device lacks required external safety 'watchdog' circuit.
FDA root cause: Other
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.
Quantity in commerce: 170
Distribution: The monitors were distributed to 8 hospitals in SC, WI, CA, MN, TX, MD and NV, as well as two hospitals in France.
Product codes and lots: All serial numbers are involved.

Product code HGM

K021135Class IIModel 2120Is Series Maternal/fetal MonitorGe Medical Systems Information Technologies / cleared 2002-05-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)