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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Smart Disclosure System, Model 92810

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 Class 2 Recall
Spacelabs Smart Disclosure System, Model 92810
see related information
Date Posted January 17, 2013
Recall Status1 Terminated on July 08, 2013
Recall Number Z-0694-2013
Recall Event ID 63931
Premarket Notification
510(K) Number
K110779 
Product Classification Computer, Diagnostic, Programmable - Product Code DQK
Product 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.
Code Information ICS G2 Smart Disclosure Model 92810, Version 4.03. There are no serial numbers.
Recalling Firm/
Manufacturer
Spacelabs Healthcare, Llc
5150 220th Ave Se
Issaquah, Washington 98029-6834
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Spacelabs Healthcare
800-522-7025 Ext. 2
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Software Design
Action Spacelabs has sent the Urgent -Medical Device Correction Spacelabs Healthcare ICS G2 Version 4.03 Model 92810 Smart Closure letter, dated 19 December 2012, to all U.S. customers. The firm plans to send a customer letter (translated as necessary) via e-mail to all international subsidiaries and distributors of record on December 27, 2012. The letter is addressed to Hospital Administrator/Biomedical Manager/Office Manager. Users are advised on the following actions: 1) Advise your staff of this potential failure and advise them to always click the "Refresh" button when scrolling to new waveform data prior to printing or viewing waveform information or storing saved events. 2) We will contact you at the earliest possible date to schedule a convenient time for your hospital to upgrade your affected software at no cost. Customers with questions can contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
Quantity in Commerce 27 in US and 17 International
Distribution Worldwide Distribution-USA including Puerto Rico and the states of California, Florida, Iowa, Illinois, Louisiana, Michigan, Minnesota, North Carolina, South Carolina, Texas, and Washington, and the countries of Argentina, Mexico, France, and India.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = SPACELABS HEALTHCARE
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