Class 2 Device Recall

• Date Initiated by Firm: May 07, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on April 08, 2006
• Recall Number: Z-1007-04
• Recall Event ID: 29038
• Product Classification: Detector And Alarm, Arrhythmia - Product Code DSI
• Product: Ultraview Universal Clinical Workstation Model 90385.
• Code Information: serial numbers 385-3xxxxx or higher
• FEI Number: 3010157426
• Recalling Firm/ Manufacturer: Spacelabs Medical Inc.; 5150 220th Ave Se; Issaquah WA 98029
• For Additional Information Contact: 800-522-7025
• Manufacturer Reason for Recall: Potential for telemetry channels to drop off display.
• FDA Determined Cause: Other
• Action: For all US customers, a Medical Device Correction letter was mailed on May 7, 2004 via courier instructing their customers to insure all monitored patients are displayed. The letter also instructed customers to move the printer to another central monitor as well as having a Field Service Engineer install new software when it becomes available. This letter was also mailed to international customers on May 14, 2004.
• Quantity in Commerce: 142 units
• Distribution: The firm distributes to hospitals nationwide. The firm also distributes to distributors internationally.
• 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.