510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-3048-2011

Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor...

Draeger Medical Systems, Inc. / initiated 2011-07-29 / Terminated / root cause: design
FDA source (opens on fda.gov)

Draeger Medical Systems, Inc. began a recall of Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult... on . 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 , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-3048-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Draeger Medical Systems, Inc.
Product
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.
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
29
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) 6001246076, 6001246575, 6001247173, 6001365874, 6001067474, 6001073681, 6001073779, 6001073877, 6001095176, 6001098966, 6001099466, 6001069472, 6001077080, 6001198466, 6001216679, 6001229674, 6001208082, 6001211782, 6001218178, 6001220086, 6001243676, 6001246771, 6001245968, 6001357179, 6001214877, 6001075679, 6001077178, 6001083180, and 6001095773.