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Terminated

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

FDA Recall Z-0092-04 · Posted 2003-11-06

Recalling FirmGeneral Electric Medical Systems Information Technology
Recall StatusTerminated
Product CodeDSI
Date Initiated2002-06-14
Date Terminated2005-11-08
Product Quantity2809 monitors and 238 software update kits

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.

Firm 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.

Root Cause

Other

Distribution Pattern

The devices were distributed nationwide in the United States and worldwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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