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.
Reported: August 15, 2018 Initiated: June 28, 2018 #Z-2738-2018
Product Description
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.
Reason for Recall
The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
Details
- Recalling Firm
- Datex-Ohmeda, Inc.
- Units Affected
- 417 units
- Distribution
- 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.
- Location
- Madison, WI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Datex-Ohmeda, Inc.. Units affected: 417 units.
Why was this product recalled? ▼
The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 15, 2018. Severity: Moderate. Recall number: Z-2738-2018.
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