Reported Jan 23, 2013 · Terminated
Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2,…
Spacelabs Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spacelabs Healthcare, Llc · 5150 220th Ave Se · Issaquah, WA · 98029-6834
Is this the product you have?
- Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. Standard reports are available from Smart Disclosure, including saved events, disclosure, trends, histogram, and summary. The Spacelabs Smart Disclosure System, Model 92810 is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. Smart Disclosure is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired. The intended use of the Spacelabs Smart Disclosure is to interface with the Spacelabs monitoring network, providing the user with a means of recalling waveform information and performing retrospective analysis. The most recent 72 hours of monitored patient ECG waveform data can be analyzed, with each analysis limited to 24 hours or less.
- Lot codes and dates
ICS G2 Smart Disclosure Model 92810Version 4.03. There are no serial numbers
- Amount recalled
- 27 in US and 17 International
Where it was sold
Why it was recalled
Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2, Version 4.03, Clinical Access portion of Smart Disclosure, Model 92810.
This product could cause temporary or reversible health problems — stop using it.
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