FDA Medical Device Recalls (openFDA)
Draeger Medical Systems, Inc.: 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.
- Recall number
- Z-3047-2011
- 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.
- Status
- Terminated
- Initiated
- 2011-07-29
- Posted
- 2011-08-22
- Terminated
- 2012-08-16
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K070566"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 2510954
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28