Devices

Device Recall Gamma X XL Portable Patient Monitor

Model / Serial
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.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
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 Description
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.
Manufacturer
Draeger Medical Systems, Inc.
1 Event
- Recall of Device Recall Gamma X XL Portable Patient Monitor

Manufacturer

Draeger Medical Systems, Inc.

Manufacturer Address
Draeger Medical Systems, Inc., 3135 Quarry Rd, Telford PA 18969-1042
Manufacturer Parent Company (2017)
Stefan Dräger GmbH
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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