Z-0250-04

Solar 9500 Information Monitor with software version 3A

Name: Z-0250-04 Solar 9500 Information Monitor with software version 3A
Creator: General Electric Medical Systems Information Technology
Published: 2003-11-10
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2003-11-10 / Terminated / root cause: software

FDA source

General Electric Medical Systems Information Technology began a recall of Solar 9500 Information Monitor with software version 3A on 2003-11-10. The reason FDA records is "Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0250-04
Status: Terminated
Initiated: 2003-11-10
Posted: 2003-12-18
Terminated: 2005-11-23
Recalling firm: GE Medical Systems Information Technologies, Inc.
Product: Solar 9500 Information Monitor with software version 3A.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first.
Root cause tag: software
FDA root cause: Other
Action: A letter dated November 10, 2003 was sent to the consignees. The letter recommended certain actions to avoid the problems and provided options for the software to be updated.
Quantity in commerce: maximum 648 Solar 9500s with Version 3A software (297 Solar 9500 Vers. 3A software were manufactured plus 131 software update kits to update multiple)
Distribution: The product was distributed to consignees located nationwide in the United States and worldwide.
Product codes and lots: Solar 9500 Information Monitor with software version 3A.

Product code MHX

K030575Class IIModification to Solar 9500 Information MonitorGe Medical Systems Information Technologies / cleared 2003-03-21

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)