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U.S. Department of Health and Human Services

Class 2 Device Recall Infinity Delta Portable Patient Monitor

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  Class 2 Device Recall Infinity Delta Portable Patient Monitor see related information
Date Initiated by Firm July 29, 2011
Date Posted August 22, 2011
Recall Status1 Terminated 3 on August 16, 2012
Recall Number Z-3047-2011
Recall Event ID 59568
510(K)Number K070566  
Product Classification Physiological Patient Monitor (with Arrhythmia Detection or Alarms) - Product Code MHX
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.
Code Information 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. 
Recalling Firm/
Manufacturer		 Draeger Medical Systems, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Rebecca Dolloff
978-379-8573
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = Draeger Medical Systems, Inc.
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