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U.S. Department of Health and Human Services

Class 2 Device Recall Draeger Infinity Acute Care System (IACS) Monitoring Solution

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  Class 2 Device Recall Draeger Infinity Acute Care System (IACS) Monitoring Solution see related information
Date Initiated by Firm December 13, 2012
Date Posted March 11, 2013
Recall Status1 Terminated 3 on May 20, 2013
Recall Number Z-0939-2013
Recall Event ID 64447
510(K)Number K093788  K113798  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo)

Physiological patient monitoring system.
Code Information Catalog Number MS20783 (Infinity MCable-Dual Hemo)
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact
215-721-5400
Manufacturer Reason
for Recall		 The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.
FDA Determined
Cause 2		 Labeling design
Action Drager sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-543-5047 for questions relating to this notice.
Quantity in Commerce 260
Distribution Distributed in the states of CA, IL, and MA.
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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