Z-3047-2011

Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital...

Name: Z-3047-2011 Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital...
Creator: Draeger Medical Systems, Inc.
Published: 2011-07-29
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2011-07-29 / Terminated / root cause: design

FDA source

Draeger Medical Systems, Inc. began a recall of Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients... on 2011-07-29. The reason FDA records is "Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3047-2011
Status: Terminated
Initiated: 2011-07-29
Posted: 2011-08-22
Terminated: 2012-08-16
Recalling firm: Draeger Medical Systems, Inc.
Product: Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.
Root cause tag: design
FDA root cause: Device Design
Action: Draeger Medical sent an "Urgent Medical Device Recall Notification" letters dated July 2011 to all affected customers. The letter included product and problem affected. The letter informed the customer a Draeger representative will contact them to upgrade the system. Until the solution is implemented, Draeger recommends the Delta and/or Gamma XXL may be used. If the affected monitors become inoperative or activate without user interaction, Draeger advises removing the monitor from service and contacting a Draeger representative. For questions or for information on this recall please call Draeger Service at (800) 543-5047 (press 1 at the prompt, then 2, then 32349).
Quantity in commerce: 32
Distribution: Worldwide Distribution - (USA) Nationwide distribution including the states of AK, FL, LA, MN, MS, MO, NJ, NC, OH, OK, PA, TN, TX, NC, NH, NJ, NY, WV, and WI; and the countries of Australia, Austria, Argentina, Bahrain, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, France, Germany, Georgia, Greece, Hungary, Italy, Ireland, India, Kazakhstan, Latvia, Macedonia, Malaysia, Mexico, Netherlands, Norway, Russian Fed., Romania, Saudi Arabia, Slovakia, Spain, South Africa, Switzerland, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.
Product codes and lots: Catalog Number(s): MS18597/MS18852 with serial numbers (US): 6001227774, 6001229772, 6001083376, 6001100483, 6001191277, 6001193373, 6001272680, 6001263779, 6001233678, 6001281679, 6001306582, 6001078774, 6001238370, 6001212879, 6001282972, 6001285969, 6001296369, 6001296467, 6001267374, 6001316580, 6001103186, 6001282776, 6001233580, 6001242579, 6001246174, 6001267472, 6001465775, 6001093775, 6001219774, 6001230476, 6001234873, and 6001235676.

Product code MHX

K070566Class IIInfinity Delta/delta Xl/ Kappa/ Gamma X Xl/ Vista Xl/ Sc7000/sc8000/ Sc9000xlDraeger Medical Systems, Inc. / cleared 2007-06-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)