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Ultraview sl command module
Official notice
2 Jun 2023
Last checked
2 Jun 2023
An official Health Canada notice concerns Ultraview sl command module. Software versions prior to 2.04 show a waveform while in suspend processing, while software version 2.04 and above do not show a waveform. Both software versions show an error message stating "ECG processing suspended" in the waveform zone, "?" in the heart rate, SpO2, and ST segment values, and a message stating "ECG ALM off" will replace the alarm limits. Hospitals may have multiple products concurrently running multiple software versions. The causal chain would be the user who is unaware of the different versions failing to recognize suspend state due to the presence of the waveform, leaving the patient in suspend with alarms inactive, a cardiac event occurring, and user failing to detect the condition with alarms inactive. Recall start date: May 23, 2023 Published 2023-06-02.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73748
Official notice
2023-06-02
The hazard
The hazard
Software versions prior to 2.04 show a waveform while in suspend processing, while software version 2.04 and above do not show a waveform. Both software versions show an error message stating "ECG processing suspended" in the waveform zone, "?" in the heart rate, SpO2, and ST segment values, and a message stating "ECG ALM off" will replace the alarm limits. Hospitals may have multiple products concurrently running multiple software versions. The causal chain would be the user who is unaware of the different versions failing to recognize suspend state due to the presence of the waveform, leaving the patient in suspend with alarms inactive, a cardiac event occurring, and user failing to detect the condition with alarms inactive. Recall start date: May 23, 2023
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Spacelabs Healthcare, Ultraview Sl Command Module.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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