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Terminated

Infinity Gamma X XL 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.

FDA Recall Z-3048-2011 · Posted 2011-08-22

Recalling FirmDraeger Medical Systems, Inc.
Recall StatusTerminated
Product CodeMHX
Date Initiated2011-07-29
Date Terminated2012-08-16
Product Quantity29

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.

Firm 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).

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070566INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XLDraeger Medical Systems, Inc. · 2007-06-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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