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U.S. Department of Health and Human Services

Class 2 Device Recall Infinity Docking Station (IDS)

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 Class 2 Device Recall Infinity Docking Station (IDS)see related information
Date Initiated by FirmNovember 17, 2006
Date PostedDecember 19, 2006
Recall Status1 Terminated 3 on November 19, 2008
Recall NumberZ-0301-2007
Recall Event ID 36856
510(K)NumberK060039 
Product Classification patient monitor - Product Code MHX
ProductInfinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.
Code Information Model numbers 4715319, 5206110, 5732388, and 7489375.
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information ContactKathy Anderson
215-721-5400
Manufacturer Reason
for Recall		Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.
FDA Determined
Cause 2		Other
ActionThe recaling firm issued a recall letter to the US customers 11/17/2006 via certified mail. An authorized service representative will inspect each potentially affected unit. If a unit is found to have an affected docking station, the unit will be repaired or replaced free or charge. Notification to international customers will occur through the international subsidiaries.
Quantity in Commerce23,345 units - 4336 US
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MHX
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