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

• Date Initiated by Firm: October 17, 2008
• Date Posted: August 25, 2010
• Recall Status: Terminated on September 29, 2010
• Recall Number: Z-2270-2010
• Recall Event ID: 50226
• 510(K)Number: K063490
• Product Classification: Programmable Diagnostic Computer - 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 WA 98029-6834
• For Additional Information Contact: 425-657-7200 Ext. 5970
• 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: 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQK and Original Applicant = SPACELABS MEDICAL INC.