Class 2 Device Recall DatexOhmeda

• Date Initiated by Firm: September 16, 2002
• Date Posted: March 05, 2003
• Recall Status: Terminated on July 02, 2004
• Recall Number: Z-0610-03
• Recall Event ID: 25501
• 510(K)Number: K010463 K011670
• Product Classification: Oximeter - Product Code DQA
• Product: Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT)
• Code Information: All serial numbers of the units distributed prior to the recall. September 16, 2002
• Recalling Firm/ Manufacturer: Datex-Ohmeda; 3030 Ohmeda Dr. Box 7550; Madison WI 53707
• Manufacturer Reason for Recall: Falsely high blood oxygen saturation readings in some circumstances could result in no alarm in a critical life-threatening situation.
• FDA Determined Cause: Other
• Action: 'Medical Device Advisory Notice' letters dated September 16, 2002 were sent to the consignees, gave recommendations about alternative monitoring for certain patients, and stated that there would be a field correction to reduce the possibility of the problem.
• Quantity in Commerce: 1019
• Distribution: Nationwide in the United States and worldwide.
• 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 and Original Applicant = DATEX-OHMEDA; 510(K)s with Product Code = DQA and Original Applicant = DATEX-OHMEDA, INC.