Solar 8000M Patient Monitor with software versions 3A, 3B and 3C
This recall has been terminated (originally issued November 6, 2003).
- Recall Initiated
- June 14, 2002
- Posted
- November 6, 2003
- Terminated
- November 8, 2005
- Recall Number
- Z-0092-04
- Quantity
- 2809 monitors and 238 software update kits
- Firm Location
- Milwaukee, WI
- Official Source
- View on FDA website ↗
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.
Distribution
The devices were distributed nationwide in the United States and worldwide.
Lot / Code Info
All devices with Solar 8000M software versions 3A, 3B or 3C are affected
Root Cause
Other
Action Taken
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.