FDA-Device2018-08-15Class II
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.
Datex-Ohmeda, Inc.
Hazard
The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
Sold states
Worldwide Distribution: US (nationwide) to: Washington, DC and countries of: Algeria, Bangladesh, Brazil, Chile, China, Colombia, Germany, Greece, Guatemala, Honduras, India, Indonesia, Iran, Iraq, Italy, Kenya, Lebanon, Malaysia, Maldives, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nigeria, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Tunisia, Turkey, United Arab Emirates, and Vietnam.
Affected count
417 units
Manufactured in
3030 Ohmeda Dr, N/A, Madison, WI, United States
Products
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2738-2018Don't want to check this manually?
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