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U.S. Department of Health and Human Services

Class 2 Device Recall Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure.

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 Class 2 Recall
Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure.
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Date Posted August 25, 2010
Recall Status1 Terminated on September 29, 2010
Recall Number Z-2270-2010
Recall Event ID 50226
Premarket Notification
510(K) Number
K063490 
Product Classification Computer, Diagnostic, Programmable - Product Code DQK
Product Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. 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.
Code Information Software version V04.00.02 was shipped on 06/30/2008. The 92810 is a software application installed on an off-the-shelf computer and is not serialized. Spacelabs uses software versions and ship dates for identification and traceability purposes.
Recalling Firm/
Manufacturer
Spacelabs Healthcare, Incorporated
5150 220th Ave Se
Issaquah, Washington 98029-6834
Manufacturer Reason
for Recall
Potential for device to print out the wrong waveform data for the time indicated in the printout or display.
FDA Determined
Cause 2
DESIGN: Device Design
Action On 07/17/2008, Spacelabs Healthcare began sending the MEDICAL DEVICE CORRECTION letter to their consignees. The letter informs the consignees that there is an issue involving ICS G2 Smart Disclosure (Model 92810) which causes the display or printing of an incorrect waveform for the time indicated in the printout or display. The consignees are advised whether to discontinue to use the device until the firm upgrades the system. If the consignees decide to continue to use the device, then they should discontinue any use of the "Refresh" button. When they print or view waveform reports,t hey should utilize the Saved Event view functionality of the product rather than Arrhythmia, Alarm or Waveform Views. If the printing from the Arrhythmia, Alarm, or Waveform views, the consignees must visually inspect the print out and verify that the waveform contains what you expected to see printed. The consignees could contact Spacelabs Healthcare at 1-800-522-7052 or 1-425-657-7200, x5089 for any questions about the corrective actions of the affected device. The firm's field service engineer will make a schedule a mutually agreeable time with the consignees to update the ICS G2 system at free of charge.
Quantity in Commerce 135 units
Distribution Worldwide Distribution -- US, Turkey, Chile, Brazil, Netherlands, Puerto Rico, Switzerland, Australia, Czech Republic, Canada, Italy, Singapore, France, Germany, and Israel.
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 MEDICAL INC.
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