Z-0092-04

Solar 8000M Patient Monitor with software versions 3A, 3B and 3C

Name: Z-0092-04 Solar 8000M Patient Monitor with software versions 3A, 3B and 3C
Creator: General Electric Medical Systems Information Technology
Published: 2002-06-14
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2002-06-14 / Terminated

FDA source

General Electric Medical Systems Information Technology began a recall of Solar 8000M Patient Monitor with software versions 3A, 3B and 3C on 2002-06-14. The reason FDA records is "Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display, and selected...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0092-04
Status: Terminated
Initiated: 2002-06-14
Posted: 2003-11-06
Terminated: 2005-11-08
Recalling firm: GE Medical Systems Information Technologies, Inc.
Product: Solar 8000M Patient Monitor with software versions 3A, 3B and 3C
Product code: DSI Detector And Alarm, Arrhythmia
Reason for recall: Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display, and selected gain settings for a selected waveform.
FDA root cause: Other
Action: A 'Patient Safety Alert' letter dated June 14, 2002 was sent to the consignees. The letter recommended certain actions to avoid the problems and stated that the firm''s field service team would contact the consignees to schedule a software revision to eliminate the problem.
Quantity in commerce: 2809 monitors and 238 software update kits
Distribution: The devices were distributed nationwide in the United States and worldwide.
Product codes and lots: All devices with Solar 8000M software versions 3A, 3B or 3C are affected

Product code DSI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)