Z-0301-2007

Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715319, 5206110...

Name: Z-0301-2007 Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715319, 5206110...
Creator: Draeger Medical, Inc.
Published: 2006-11-17
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2006-11-17 / Terminated

FDA source

Draeger Medical, Inc. began a recall of Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375 on 2006-11-17. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0301-2007
Status: Terminated
Initiated: 2006-11-17
Posted: 2006-12-19
Terminated: 2008-11-19
Recalling firm: Draeger, Inc.
Product: Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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 root cause: Other
Action: The 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 commerce: 23,345 units - 4336 US
Distribution: Nationwide
Product codes and lots: Model numbers 4715319, 5206110, 5732388, and 7489375.

Product code MHX

K060039Class IIInfinity Delta and Kappa Series Monitors with Vf6 ModificationsDraeger Medical Systems, Inc. / cleared 2006-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)