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U.S. Department of Health and Human Services

Class 2 Device Recall Draeger

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  Class 2 Device Recall Draeger see related information
Date Initiated by Firm December 10, 2013
Date Posted January 10, 2014
Recall Status1 Terminated 3 on May 20, 2015
Recall Number Z-0714-2014
Recall Event ID 67056
510(K)Number K113798  
Product Classification Monitor, physiological, patient (with arrhythmia detection or alarms) - Product Code MHX
Product Draeger Infinity Acute Care System Monitoring Solution
Code Information with software versions VG2.0.3 and higher.
Recalling Firm/
Manufacturer		 Draeger Medical Systems, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Customer Support
215-721-5400
Manufacturer Reason
for Recall		 After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.
FDA Determined
Cause 2		 Software design
Action An Urgent Medical Device Recall Letter, dated December 2013, was sent to Users. Once available Drager will update components of the IACS Monitoring Solution System.
Quantity in Commerce 439
Distribution US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.
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 = MHX and Original Applicant = Draeger Medical Systems, Inc.
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