Class 2 Device Recall Oridion Capnostream20 (Monitor)

• Date Initiated by Firm: July 28, 2007
• Date Posted: November 28, 2007
• Recall Status: Terminated on September 08, 2008
• Recall Number: Z-0178-2008
• Recall Event ID: 44926
• 510(K)Number: K060065
• Product Classification: Oximeter (Monitor) - Product Code DQA
• Product: Capnostream20 Monitor with Masimo Pulse Oximetry Module - Part Number: CS 08659 - Oridion Medical
• Code Information: Serial Numbers: B300001003 B300001008 B300001018 B300001043 B300001044 B300001050
• Recalling Firm/ Manufacturer: Oridion Capnography Inc; 160 Gould St; Needham Heights MA 02494-2313
• For Additional Information Contact: 781-453-0500
• Manufacturer Reason for Recall: Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.
• FDA Determined Cause: Process design
• Action: Oridion sent Dear Customer letters dated, August 21, 2007, informing users that a new monitor with the improved handle will be shipped by August 31, 2007.
• Quantity in Commerce: 6
• Distribution: Nationwide Distribution- including states of AZ, CA, FL, MA, MO, OH, TX, WA, and WI,
• 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 = DQA