Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor, display, trend and print a patient''s physiological parameters. The device has a 12.1 inch color display and has a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, non-invasive blood pressure, respiration, continuous temperature and IV Drug Calculations. Optional digital displays are provided for invasive blood pressure (up to four) anesthetic agents, O2 and NO2, ST, and CO2
Hazard
Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.
What You Should Do
Remedy
Datascope sent out a Field Correction notice on 9/7/2005 to all Hospital administrators who have the monitors. This was sent out via certified mail, return receipt requested. A Datascope Service Rep will conduct and document the corrective action during a visit to the customer.
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Products
Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor, display, trend and print a patient''s physiological parameters. The device has a 12.1 inch
- Brand
- Datascope Corp
- UPC
- All Spectrum Monitors that have the following Software Versions: A.19, A.20, B.23, B.24, B.25, B.27, C.18, D.07, E.07, F.09, F.16, F.17, F.26.
Units Affected
2318 monitors