FDAFDA · Food and drugs·Recall number Z-0463-2019
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume.
Published December 12, 2018 · Recall initiated: October 5, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Worldwide Distribution: US (Nationwide) including Puerto Rico, and to countries of: Albania, Argentina, Australia, Austria, Bangladesh, Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Honduras, Hungary, India, Indonesia, Iraq, Italy, Japan, Kazakhstan, Korea (Republic of), Kuwait, Latvia, Lebanon, Libya, Malaysia, Maldives, Mexico, Myanmar, Nepal, Netherlands, Nicaragua, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
- Lot
- a) 2066713-001 Lot Numbers: 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, 18/00130 b) 2083208-001 Lot Numbers: 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, 18/00130
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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