Z-2283-2010

Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal...

Name: Z-2283-2010 Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal...
Creator: Draeger Medical Systems, Inc.
Published: 2010-06-04
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2010-06-04 / Terminated / root cause: design

FDA source

Draeger Medical Systems, Inc. began a recall of Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport... on 2010-06-04. The reason FDA records is "Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge 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-2283-2010
Status: Terminated
Initiated: 2010-06-04
Posted: 2010-08-26
Terminated: 2012-07-30
Recalling firm: Draeger Medical Systems, Inc.
Product: Infinity Delta/Gamma X XL Patient Monitor. 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 become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically.
Root cause tag: design
FDA root cause: Device Design
Action: Draeger Medical issued "Urgent-Medical Device Recall Notification" letters to affected consignees. The Delta/Gamma X XL monitor keyboards will be updated with new material at each affected facility. If the keys on affected monitors become inoperative or activate without user interaction, the customer is instructed to remove the monitor from service and contact Draeger at 978-379-8573. A Technical Service Bulletin (TSB) will be distributed globally, instructing subsidiaries to inform international customers.
Quantity in commerce: 8675 units
Distribution: Worldwide Distribution - United States, including the states of AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KS, LA, MA, ME, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, WO, and W, and the countries of United Arab Emirates, Angola, Argentina, Austria, Australia, Bosnia, Belgium, Bulgaria, Benin, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Serbia, Czech Republic, Germany, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Coratia, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Jordan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon,Lithuania, Latvia, Libya, Morocco, Macedonia, Martinique, Mexico, Netherlands, Norway, Nepal, Peru, Poland, Puerto Rico, Portugal, Qatar, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovak Republic, Turkmenistan, Turkey, Ukraine, Uruguay, Venezuela, Mayotte and South Africa. The government accounts are Bay Pines VAMC, Bay Pines, FL; Naval Medical Center, Portsmouth, VA; and Walter Reed Army Medical Center, Washington, DC.
Product codes and lots: Catalog Number: MS18597

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)