Z-0115-06

BirthNet OB Data Management System 91861

Name: Z-0115-06 BirthNet OB Data Management System 91861
Creator: Spacelabs Medical Incorporated
Published: 2005-10-13
License: https://open.fda.gov/license/

GE Healthcare / initiated 2005-10-13 / Terminated

FDA source

Spacelabs Medical Incorporated began a recall of BirthNet OB Data Management System 91861 on 2005-10-13. The reason FDA records is "Potential for incorrect weight to be displayed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0115-06
Status: Terminated
Initiated: 2005-10-13
Posted: 2005-11-01
Terminated: 2011-01-17
Recalling firm: GE Healthcare
Product: BirthNet OB Data Management System 91861
Product code: HGM System, Monitoring, Perinatal
Reason for recall: Potential for incorrect weight to be displayed.
FDA root cause: Other
Action: On 10/13/04 the firm sent letters to customers advising of the error, and that software to correct the problem will be released the end of October. Service personnel will install new software.
Quantity in commerce: 44 devices
Distribution: Distribution was to 44 medical facilities/hospitals nationwide.
Product codes and lots: All serial numbers involved

Product code HGM

K965008Class IIBirthnet II Perinatal Patient Data Management SystemSpacelabs Medical, Inc. / cleared 1997-12-16

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)