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.
- Company
- Draeger Medical Systems, Inc.
- Recall Initiated
- June 4, 2010
- Posted
- August 26, 2010
- Terminated
- July 30, 2012
- Recall Number
- Z-2283-2010
- Quantity
- 8675 units
- Firm Location
- Telford, PA
Reason for Recall
Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically.
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.
Lot / Code Info
Catalog Number: MS18597
Root Cause
Device Design
Action Taken
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.